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Research Article

Essential newborn care practice and its predictors among mother who delivered within the past six months in Chencha District, Southern Ethiopia, 2017

Roles Conceptualization, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Resources, Software, Supervision, Validation, Visualization, Writing – original draft, Writing – review & editing

* E-mail: [email protected]

Affiliation Department of Nursing, College of Medicine and Health Sciences, Arba Minch University, Arba Minch, Ethiopia

Roles Data curation, Formal analysis, Software, Writing – review & editing

Affiliation School of Public Health, College of Health and Medical Sciences, Haramaya University, Harar, Ethiopia

Roles Formal analysis, Methodology, Software, Visualization, Writing – review & editing

Affiliation School of Nursing and Midwifery, College of Health and Medical Sciences, Haramaya University, Harar, Ethiopia

Roles Methodology, Project administration, Software, Visualization, Writing – original draft, Writing – review & editing

Roles Investigation, Resources, Writing – original draft, Writing – review & editing

Affiliation Business Development Officer with CARE Ethiopia and Cuso International, Monitoring and Evaluation Advisor, Harar, Ethiopia

Roles Software, Supervision, Visualization, Writing – original draft

• Abera Mersha, 
• Nega Assefa, 
• Kedir Teji, 
• Shitaye Shibiru, 
• Rasha Darghawth, 
• Agegnehu Bante

• Published: December 11, 2018
• https://doi.org/10.1371/journal.pone.0208984
• Reader Comments

Introduction

Components of essential newborn care and neonatal resuscitation are proven interventions for reducing neonatal mortality rate and stillbirth rates. Various studies have been conducted, but they failed in assessing health workers that delivered essential newborn care, facets of the health care system, and different traditional beliefs. As such, the primary aim of this study is to fill the gaps of the aforementioned previous studies, assess mothers’ current practice of essential newborn care and identify factors affecting newborn care practices in Chencha District, Southern Ethiopia.

A mixed type, community-based cross sectional study was conducted among 630 study participants by using one-stage cluster sampling method. Three focus group discussions (FGD) with purposively selected 18 mothers were involved for qualitative study. Data entry was carried out by Epi data version 3.1 and analysis was done by SPSS window version 22. Binary logistic regression was used to identify predictors. Qualitative data were analyzed deductively by using thematic framework analysis approach by using Open Code version 4.02.

This study found that 38.4% of mothers had good practices in essential newborn care. Of the neonates, 52.9% received safe cord care, 71.0% received optimal thermal care and 74.8% had good neonatal feeding. Factors such as mothers receiving antenatal care, attending pregnant mothers meetings, receiving immediate postnatal care, wealth index, whether a complication was faced during delivery and overall knowledge of mothers were statistically significantly associated with practice.

Conclusions

This study indicated that the current rate of essential newborn care practice was low. As such, strengthening the provision of antenatal and postnatal care services, information communication education and behavioral change communications on essential newborn care are recommended.

Citation: Mersha A, Assefa N, Teji K, Shibiru S, Darghawth R, Bante A (2018) Essential newborn care practice and its predictors among mother who delivered within the past six months in Chencha District, Southern Ethiopia, 2017. PLoS ONE 13(12): e0208984. https://doi.org/10.1371/journal.pone.0208984

Editor: Vijayaprasad Gopichandran, ESIC Medical College & PGIMSR, INDIA

Received: September 23, 2018; Accepted: November 28, 2018; Published: December 11, 2018

Copyright: © 2018 Mersha et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: All relevant data are within the manuscript and its Supporting Information files.

Funding: Haramaya University provided funds for the data collection and stationary materials of this research work with a project grant code of Acct. No GOV-1000019938984. The website of the university is [email protected] . The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

Globally, there have been great strides made in reducing the number of neonatal deaths, declining from 5.1 million in 1990 to 2.7 million in 2015. However, the decline in neonatal mortality from 1990 to 2015 has been far slower than that of post-neonatal under-5 mortality. This pattern applies to most low- and middle-income countries, as current global data shows that approximately 99% of maternal and newborn mortality occurs in the developing world [ 1 , 2 ]. Annually, approximately 1.16 million African babies die in the first 28 days of life. The burden of neonatal mortality and ill health is concentrated among the marginalized and poorest populations in countries of Sub-Saharan Africa and South Asia. The majority of neonatal mortality in developing countries is related to conditions of labor, intrapartum and poor immediate newborn care practices [ 3 – 5 ]. More than 60% of infant and 40% of under-five deaths in Ethiopia are neonatal deaths. This dire situation calls for extensive health care services [ 6 ].

To illustrate the, UNICEF has stated that, “the period around birth constitutes a critical window of opportunity for prevention and management of maternal and newborn complications, which can otherwise prove fatal” [ 7 ]. Essential newborn care (ENC) is a set of measures every newborn baby requires regardless of where it is born or its size. It is designed to protect the newborn in adverse environmental condition [ 1 , 8 , 9 ] and is a framework that should be applied immediately after birth, continued at least for the first seven days. Components of ENC and neonatal resuscitation are proven interventions for reducing neonatal mortality rate and stillbirth rate [ 10 ].

There are inequities affecting the access and utilization of maternal, neonatal and child health services due to women’s age, education, household wealth index and distance of the women’s household from the nearest health facility still exist in rural Ethiopia [ 11 ]. Different studies conducted in Ethiopia stated that the prevalence of essential newborn care practice was low [ 12 – 14 ].

Community-based newborn care implementation programs in Ethiopia involve the scaling-up of community-based maternal and newborn health services, including the provision of immediate newborn care, initial stimulation and resuscitation of the newborn baby, prevention and management of hypothermia, management of pre-term and low birth weight (LBW) neonates, and management of neonatal sepsis and very severe disease at community level [ 15 ].

However, various studies conducted in Ethiopia have failed in assessing the health workers that implemented ENC, health care system; there difference in socio-demographic characteristics and cultural background. To the author’s knowledge, studies have also neglected to assess the proportion of children who received ENC and factors that hinders the provision of the services among mothers. As such, the purpose of this study was to fill those gaps, assessing mother’s recent status of essential newborn care practice and identify factors hindering and promoting these practices in Chencha District, Southern Ethiopia.

Study setting, period and design

This community-based mixed study was conducted in Chencha District between February 8 and 28 th , 2017. Chencha District is one of the Districts in Gamo Gofa Zone within the South Nations, Nationalities and Peoples’ Region (SNNPR) of Ethiopia and it is located 562 Km Southwest of Addis Ababa, the capital city of Ethiopia. Chencha District has 50 kebeles (five urban and 45 rural), towns in Chencha district include Chencha, Dorze, Dokko and Ezo. The district has a total population of 140,183 people (68,970 males and 71,213 females), approximately 28,609 households [ 16 ].

All mothers who gave birth in six months prior to the study period constituted the source population. Mothers who were found in selected clusters comprised the study population for this study. The sampling unit was households and the study unit was mothers [ 17 ].

Eligibility criteria

The inclusion criteria were all mothers who gave birth in the past six months prior to the study period and were residents for at least 6 months in the study area was included in this study. Whereas, the exclusion criteria were mothers who were not mentally competent, seriously ill and whose delivered baby died prior to the data collection period [ 17 ].

Sample size determination

Epi info7 software Stat Cal was used to calculate the sample sizes. To determine the prevalence of essential newborn care practice, a single population proportion was used and to identify predictors, a double population proportion was used. The final sample size was derived through adding non-response rate of 10% to the larger sample size which was 561. So, the calculated sample size for quantitative study was 618. However, due to the cluster effect the final sample used for this study was 630 [ 17 ]. The design effect of 1.5 was used to calculate the sample sizes. For the qualitative part of the study, three focus group discussions (FGD) with six mothers on each group were involved depending on idea saturation.

Sampling procedure

For quantitative data, the one-stage cluster sampling method was used. For the qualitative data, purposive sampling was used. The Chencha district has fifty kebeles or six clusters based on topography and catchment areas, relative to the health centers. Initially, the 6 clusters were clustered in to seventeen smaller clusters. From the seventeen clusters, nine clusters were selected by simple random sampling method. However, to reach the calculated sample size, one additional cluster was added again by simple random sampling from the residual clusters. As such, the final clusters selected for this study were 10 ( Fig 1 ).

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• TIFF original image

https://doi.org/10.1371/journal.pone.0208984.g001

Data collection methods

A pre-tested, structured interview was administered and used to collect quantitative data. An interview guide for discussion was used to collect qualitative information. The data were collected by trained 7 diploma nurses and supervised by two BSc holder nurses who were fluent in the local language, Gammogna . The data collectors collected the information through a face to face interview of mothers at the household level. To generate qualitative information, an FGD was conducted. Each session of the FGD was tape recorded after getting written and signed voluntary consent from the FGD participants. Those participants were selected by principal investigator and the discussion was conducted until a saturation of ideas occurred within the group. The discussion was moderated by principal investigator and one other assistant (data collector) took notes and recorded all the information of the FGD.

Study variables and measurements

Essential newborn care practice was the dependent variable and socio-demographic and socio-economic characteristics, maternal and child health services, knowledge about ENC, health care system and traditional beliefs were independent variables for this study. The detail descriptions and measurements are given below ( Table 1 ).

https://doi.org/10.1371/journal.pone.0208984.t001

Data quality control

In order to ensure quality, the questionnaire was initially drafted in English language, and then translated in to local language, Gammogna by verified translators. Lastly, before data collection, the questionnaire was back translated in to English to ensure accuracy. Questionnaires were pre-tested in an area with a population with a similar socio-demographic status. Data were checked for completeness, accuracy, clarity and consistency before being entered in to software. Proper coding and categorization of data were maintained for the quality of the data to be analyzed. Double data entry was used to ensure validity and compare to the original data.

Data analysis and processing

The quantitative data were coded, cleaned, edited and entered into Epi data version 3.1, then exported to SPSS window version 22 for analysis. Wealth quintiles were determined by using a Principal Component Analysis (PCA). Binary logistic regression was used to assess the association between each independent variables and outcome variable. Hosmer-Lemeshow statistic and Omnibus tests conducted done for model fitness. All variables with P<0.2 in the bivariate analysis were included in the final model of multivariate analysis in order to control all possible confounders. In addition, variables which were significant in previous studies and from context point of view included in the final model even if the above criteria was not meet. A variance inflation factor >10 and standard error >2 were considered as suggesting the existence of multi co-linearity. The direction and strength of statistical association was measured by an odds ratio with 95% CI. Adjusted odds ratio along with 95%CI was estimated to identify predictors for essential newborn care practice. In this study P-value < 0.05 was considered to declare a result as a statistically significant association. The focus group discussions audios were initially transcribed verbatim in the local language, Gammogna , and then translated into English transcripts by the principal investigator. Data were analyzed deductively by using a thematic framework analysis approach and qualitative data analysis software Open Code version 4.02 was used. Each transcript was carefully screened and coded. Those codes were in turn grouped into major themes representing positive essential newborn care practices such as cord care, thermal care and neonatal feeding.

Ethics approval and consent to participate

Ethical clearance was obtained from Haramaya University, College of Health and Medical Sciences, Institutional Health Research Ethics Review Committee (HU-IHRERC). All study participants were informed about the purpose of the study, their right to refuse participation and written and signed voluntary consent was obtained from all study participants prior to the interview. The respondents were also informed that the information obtained from them was treated with utmost confidentiality.

Socio-demographic and economic characteristics

In this study, 630 participants responded to the questionnaire, with a total response rate of 100%. The majority of the respondents were in the age group 25–34 and the mean age of study participants were 29.62 (±5.082 SD). Of the respondents, the majority were married 584 (92.7%) and lived in rural locations constitutes 400 (63.5%). Orthodox Christianity was the dominant religion 489 (77.6%) among study participants ( Table 2 ).

https://doi.org/10.1371/journal.pone.0208984.t002

Maternal and child health services

Of the respondents, 533 (84.6%) had ANC follow up. Two hundred and eleven (39.6%) had one to three visits, 279 (52.4%) had four visits and 43 (8.1%) had five and more visits. During ANC follow up the majority 522 (97.9%) were advised about ENC. Two hundred twenty three (35.4%) had delivered at health center and 421 (66.8%) had immediate postnatal care. The majority of the neonates 593 (94.1%) were immunized and 528 (83.8%) mothers did not face any complications during delivery. Five hundred thirty eight (85.4%) study participants gave birth through spontaneous vaginal delivery, 83 (13.2%) included at instrumental delivery and 9 (1.4%) had caesarean delivery as data has been published elsewhere [ 17 ] ( Table 3 ). Of the respondents, 437 (69.4%) were assisted by skilled birth attendants and 68 (10.8%), 26 (4.1%), 43 (6.8%), 31 (4.9%) and 25 (4%) were assisted by a family member, neighbor, relatives/mother in law, traditional birth attendants and health extension workers during delivery.

https://doi.org/10.1371/journal.pone.0208984.t003

Essential newborn care practice

Of the respondents, 251 (39.8%) applied substances on the stump, 176 (70.1%) applied ointment/powder, 70 (27.9%) applied butter, 4 (1.6%) applied animal dung and 1 (0.4%) applied ash on the stump. Eye care was given for 456 (72.4%) of the babies and 407 (89.3%) stated the care givers were health extension workers and 49 (10.7%) stated the care givers were health professionals (nurses and midwives). Colostrum was given for 568 (90.2%) of the babies of respondents after delivery and pre-lacteal feeding was given for 90 (14.3%) of the babies. Among those who gave pre-lacteal feeding 53 (58.9%) of the mothers gave plain water, 28 (31.1%) gave butter, 8 (8.9%) gave animal milk and 1 (1.1%) gave honey. Six hundred and six (96.2%) of the newborn babies had wiped and 601 (95.4%) had wrapped the baby in cloth after delivery ( Table 4 ).

https://doi.org/10.1371/journal.pone.0208984.t004

Various instruments were used to cut the cord, with 189 (30%) respondents stating they used a new blade, 28 (4.4%) stating they used blade, and 10 (1.6%) stated using a knife. The majority, at 403 (64%) used a pair of scissors ( Fig 2 ).

Various instruments were used to cut the cord, with 189 (30%) respondents stating they used a new blade, 28 (4.4%) stating they used blade, and 10 (1.6%) stated using a knife. The majority, at 403 (64%) used a pair of scissors.

https://doi.org/10.1371/journal.pone.0208984.g002

The majority of the discussants in the qualitative findings stated that the cord was tied by thread or string and cut by a new blade if delivery occurs at home. Previously the cord was also tied by apart from the false banana plant (zaniza) . However, the communities noted they are moving away from this trend as improved awareness of the risks has been created by health extension workers. The other common practice reported by discussants was the application of fresh butter on and around the stump, whether delivery occurs at home or health care institutions.

A 32 year-old FGD discussant noted that, “I delivered my newborn three months back at home by the help of traditional birth attendants. After delivery the attendants tied the cord by thread and cut it with a new blade that I bought from market. To cut the cord, attendants measure from the babies’ abdomen by their fingers. If the cord was tied and cut after 2 fingers from the abdomen of newborn it can dropped within 2 days and if tied and cut after 3 finger from the abdomen of newborn it can dropped within 3 days……. During the first 7 days after delivery I applied fresh butter on the stump to prevent dryness and to make it soft .…”

Three hundred seventy seven (59.8%) of the study participants stated breastfeeding was initiated within one hour of delivery, 191 (30.3%) initiated immediately after delivery and 62 (9.8%) initiated after one hour of delivery ( Fig 3 ).

Three hundred seventy seven (59.8%) of the study participants stated breastfeeding was initiated within one hour of delivery, 191 (30.3%) initiated immediately after delivery and 62 (9.8%) initiated after one hour of delivery.

https://doi.org/10.1371/journal.pone.0208984.g003

A 25-year old FGD discussant mother said that, “I had antenatal care follow up at health center every month. But, I delivered at home by the help of traditional birth attendants. After delivery the attendants gave expressed water from the “utha shedo” (false banana plant) before starting breastfeeding, they consider this important for newborns to initiate breast feeding. Then the attendants ordered me to wait for some time to breastfeed the newborn. In addition, I gave fluid from “mudha” (traditional herbs) for the newborn in order to facilitate the feeding and to prevent gastric disturbance .

Four hundred eighty (76.2%) of the study participants stated that the newborn had been bathed after 24 hours post-delivery, 121 (19.2%) had bathed their newborns immediate after delivery and 29 (4.6%) had bathed them before 24 hours post-delivery ( Fig 4 ).

Four hundred eighty (76.2%) of the study participants stated that the newborn had been bathed after 24 hours post-delivery, 121 (19.2%) had bathed their newborns immediate after delivery and 29 (4.6%) had bathed them before 24 hours post-delivery.

https://doi.org/10.1371/journal.pone.0208984.g004

The majority of the discussants in the qualitative findings stated that their newborns were washed in warm water because they consider as dirty or contaminated by blood and wrapped by piece of cloth (towel) or by a new cloth to prevent from cold immediate after delivery. There were also traditional practices like applying fresh butter on the head of a newborn, covering them in a cabbage leaf and then put hat on head or wrapped by a piece of cloth.

A 27-year old FGD discussant said that, “I gave birth at home with the help of neighbors. Immediately after delivery, both mother and newborn were washed by warm water. The newborn was then wrapped in new cloth to protect him from the cold immediately after delivery, and both the mother and newborn lay close to fire. In our community, all mothers who have delivered live in a very hot house, heated by fire wood. The other important thing is to keep the newborn from cold fresh butter was putted on the head and covered by plant leaf, then cap was done or a small cloth was wrapped around the head .”

In this study 38.4% of mothers had good practice on ENC. Of the neonates, 52.9% received safe cord care, 71.0% received optimal thermal care and 74.8% had good neonatal feeding ( Table 5 ).

https://doi.org/10.1371/journal.pone.0208984.t005

Health care system

Out of the respondents, 176 (27.9%) stated that hospitals were available nearby, 124 (19.7%) had access to health center and 330 (52.4%) had access to health posts. Six hundred thirteen (97.3%) stated that these health care institutions create awareness about essential newborn care. A number of healthcare providers were involved in creating awareness including 495 (78.6%) health extension workers and health development army’s, 100 nurses (15.9%), 33 midwives (5.2%) and 2 public health officers (0.3%). Out of the study participants 572 (90.8%) stated that the distance to health care institutions were less than 5 km. The majority of the FGD discussants stated that health extension workers in home-based sessions create awareness about when to bath the newborn, when to initiate breastfeeding, cord care after delivery and about immunization. Before the prevalence health extension workers, the majority of mothers partook in traditional practices which can predispose the newborn to complications.

Predictors for essential newborn care practice

In the multivariate model antenatal care, attending pregnant mothers meeting, it was found that immediate postnatal care, wealth index of 2 nd quintile, and a good degree of knowledge by the mother about ENC were positively associated with good ENC practice. However, facing a complication during delivery was negatively associated with good practice of ENC.

Mothers who had sought antenatal care were 3.13 times and who had attending pregnant mothers meeting were 2.90 times more likely to practice good essential newborn care, (AOR = 3.13, 95%CI: 1.47, 6.64) and (AOR = 2.90, 95%CI: 1.45, 5.82). The odds of good ENC practice were 3.27 among mothers who had immediate postnatal care and 7.36 among mothers who had good knowledge about ENC, (AOR = 3.27, 95%CI: 1.99, 5.35) and (AOR = 7.36, 95%CI: 2.77, 19.59). Mothers who had faced complication during delivery were 80% less likely to practice ENC (AOR = 0.20, 95%CI: 0.11, 0.37). Mothers with a wealth index in the 2 nd quintile were 74% more likely (AOR = 1.74, 95%CI: 1.12, 2.72) to practice good ENC ( Table 6 ).

https://doi.org/10.1371/journal.pone.0208984.t006

This study found that mothers’ good practice of ENC was 38.4%, 52.9% received safe cord care, 71% received optimal thermal care and 74.8% %) had good neonatal feeding. Mothers who had antenatal care were 13% and who had attending pregnant mothers meeting were 90% more likely to practice good ENC. Mothers who had immediate postnatal care were 27% and mothers who had good knowledge about ENC were 36% more likely practice ENC. Mothers who faced complications during delivery were 80% less likely and with wealth index in the 2nd quintile were 74% more likely to practice ENC.

The prevalence of good ENC assesses in this study is in line with research conducted in North West Ethiopia (40.6%), higher than studies conducted in Awabel District, Amhara region of Ethiopia (23.1%) and Eastern Uganda (11.7%) and lower than two studies done in South West Ethiopia (59.5%) and Eastern Tigray of Ethiopia (92.9%) [ 12 – 14 , 20 , 21 ]. Health system-related factors contributing to this difference could be due to the extensive work of health extension workers and various health care institutions in awareness creation on ENC in the study area. Socio-cultural factors might include differences in the socio-cultural composition of the study groups, while other factors might include differences in the study period (e.g. studies conducted during harvest season may have differing results, and thus should and cannot be compared) and methodological weakness of the studies.

In this study 39.8% of mothers responded that substances were applied on the stump; this finding was supplemented by qualitative findings. This particular finding is higher than that found in four regions of Ethiopia (Amhara, Oromia, SNNPR and Tigray) at 21%. But, lower than the study conducted in Eastern Tigray of Ethiopia (56.8%) on another hand the qualitative finding was congruent with study done in Oromia Region of Ethiopia[ 13 , 20 , 22 , 23 ]. The reason for the above difference may be due to socio-cultural factors. The majority (95.4%) of study participants stated that newborns were wrapped by new cloth before placenta expulsion immediately after delivery. This is higher as compared with study conducted in North West Ethiopia which was 57.5%[ 12 ]. The reason for this could be due to mothers’ better awareness about thermal care by extensive work of health extension workers in community-based newborn programs and home to home visits.

As shown by this study 59.8% of mothers stated that breastfeeding was started within one hour after delivery. This is low as compared to similar studies done in Eastern Tigray of Ethiopia and North West Ethiopia which were 93.2% and 62.1% respectively. However, this is relatively high when compared to study conducted in Awabel District, Amhara region of Ethiopia which was 41.6% [ 12 , 13 , 20 ]. This difference may be due to socio-demographic factors, awareness creation gap on breastfeeding initition time and socio-cultural factors. The majority (90.2%) of study participants stated colostrum was given for the newborn. This was congruent with the pervious study done in Ethiopia which was 98.3%[ 20 ]. The qualitative finding of this study also supplements the quantitative finding. However, it contradicts with study done in Oromia Region of Ethiopia reported that colostrum or first milk was not given for the newborn because it causes infection to the newborn[ 23 ]. The reason for this may be due to socio-cultural difference.

Regarding bathing time, 76.2% of study participants stated that their newborns were bathed after 24 hours. This result is congruent with similar study done in Eastern Tigray of Ethiopia (78.4%) and high as compared to two studies done in North West Ethiopia (60.8%) and Awabel District, Amhara Region of Ethiopia (34.4%) [ 12 , 13 , 20 ]. This may be due to the extensive work of health extension workers on a home to home basis. The qualitative finding is congruent with studies done in South West of Ethiopia and Oromia Region of Ethiopia stated that newborns were washed by warm water because they consider as dirty or contaminated by blood [ 14 , 24 ]. The reason for is may be lack of knowledge about thermal care and socio-cultural factors.

In this study, mothers with a wealth index in the 2 nd quintile were 1.74 times more likely to practice good ENC. This is in line with a study conducted in Eastern Uganda[ 21 ]. Mothers who had sought antenatal care were 3.13 times more likely to practice good ENC. This is congruent with studies done in Northern Ghana, Eastern Uganda, Sindhuli District of Nepal, North West Ethiopia [ 12 , 18 , 21 , 25 ]. The odds of practice were 2.90 among mothers who attended pregnant mothers meeting. This is in line with study done in Awabel District, Amhara Region of Ethiopia[ 13 ]. Mothers who had immediate postnatal care were 3.27 times and good knowledge about essential newborn care was 7.36 times more likely to practice essential newborn care. This is inline with studies done in Awabel District, Amhara Region of Ethiopia, Nepal, Eastern Tigray of Ethiopia, and Bachauli and Khairahani [ 13 , 20 , 25 , 26 ]. The reason for this is mothers who had PNC discussed and were counseled about essentail newborn care with health extension workers or other health care providers and mothers who had good knowledge about essential newborn care is more likely to practice essential newborn care. In this study mothers who faced complication during delivery were 80% less likely to practice essential newborn care. The reason for this is it evident that mothers in complicated situation not gave care for their newborns unless conditions were resolved.

This contradicts with studies conducted in North West Ethiopia, South West Ethiopia, Nepal, Eastern Ghana and Eastern Tigray of Ethiopia [ 12 , 14 , 18 , 20 , 25 ]. The reason for this difference is due to the fact that health extension workers and other health care providers create awareness about practice for all mothers at home base regardless of age, educational level and occupation. In this study, mothers who were assisted by a skilled birth attendant during delivery were not significantly associated with good ENC practice. This is incongruent with a study done in Eastern Uganda[ 21 ]. The reason for this difference may be due to the case that some mothers reside in traditional mal-practices even if the delivery care was given by skilled birth attendant either at health care institution or at home which put the newborn in ill health.

The limitation of this study was respondents might be subjected to recall bias because the mothers failed to remember what they did for their infant in the early neonatal period. The study might not show a cause and effect relationship because the study design was cross-sectional.

This study indicated that the level of essential newborn care practice was low. There are mal-practices in which 39.8% applied substances on the stump, 14.3% and 12.1% of the study participants used un-boiled instruments to cut the cord and given pre-lacteal feeding for their newborns immediate after delivery respectively.

In general, this study identified that antenatal care, attending pregnant mothers meeting, immediate postnatal care, wealth index in the 2 nd quintile and good knowledge about ENC were independent positive predictors for good ENC practice, whereas faced complication during delivery was negative predictor for good ENC practice.

As indicated by this study, age of mother, educational status and occupation of the mother were not significantly associated with good ENC practice. This key finding has important implications for the training of ENC care providers and health extension workers who are tasked with improving ENC delivery and uptake. For example, given that educational status and occupation of the mother are not significant predictors of good ENC, it is clear that community-based strategies are effective knowledge dissemination measures.

However, given the prevalence of malpractice, there may be opportunities to engage in conversations with prominent community leaders who may be influential in altering these practices and ideally, promote the uptake of good ENC practices.

Additionally, strengthen awareness creation activities on ENC through disseminating health information and developing communication strategies to promote positive behaviours both at facility and community level. Health facilities should regularly provide ENC for newborns and take opportunities to counsel the mothers about ENC during pregnant mothers meeting and MCH services sessions. This research has provided a sound basis for the improvement of ENC information dissemination and uptake, ideally resulting in improved practices. Further research should assess the degree to which interventions designed to maximize ENC are effective.

Supporting information

S1 tool. this is the s1 english and gammogna version tool..

https://doi.org/10.1371/journal.pone.0208984.s001

Acknowledgments

The authors would like to thank Chencha District health office workers who give baseline information about study area, data collectors, supervisors, study participants and all other individuals involved in any process of this study.

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• Open access
• Published: 31 March 2021

Essential newborn care practice and its associated factors in Southwest Ethiopia

• Haimanot Abebe   ORCID: orcid.org/0000-0001-5885-5982 1 ,
• Daniel Adane 2 &
• Solomon Shitu 2  

Archives of Public Health volume  79 , Article number:  42 ( 2021 ) Cite this article

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Essential newborn care is a wide-ranging strategy intended to improve the health of newborns by implementing appropriate interventions. Approximately in 2018, an estimated 2.5 million children died in their first month of life, which is approximately 7000, newborns every day, with about a third of all neonatal deaths occurring within the first day after birth. Even though the most cause of death is preventable the burden of neonatal death is a still high in developing countries including Ethiopia. Therefore this study is aimed to assess the level of essential newborn care practice among mothers who gave birth within the past six months in Gurage Zone, Southwest Ethiopia .

A community-based cross-sectional study was conducted among mothers who gave birth within the past six months in Gurage Zone, Southwest Ethiopia. For the quantitative part, 624 study participants were involved by using a multi-stage sampling method. A systematic random sampling technique was to reach the study subjects. Data entry was carried out by Epi data version 4.0.0 and analysis was done by SPSS window version 24. Binary and multivariate logistic regressions were used to identify associated factors. For the qualitative part, three focus group discussions (FGD) with purposively selected 30 mothers were involved. The data were analyzed deductively by using the thematic framework analysis approach by using Open code version 4.02.

Overall good essential newborn care practice was found to be 41.0% [95%CI, 36.6–44.7]. Being urban residence [AOR 1.70, 95%CI: 1.03–2.79], attending antenatal care visit [AOR = 3.53, 95%CI: 2.14–5.83], attending pregnant mothers meeting [AOR = 1.86, 95%CI: 1.21–2.86], had immediate postnatal care [AOR = 3.92, 95% CI: 2.65–5.78], and having good knowledge about ENC [AOR = 2.13, 95% CI: 1.47–3.10] were significantly associated with good essential newborn care practice.

This study indicated that the magnitude of essential newborn care practice was low. Thus, a primary health care provider should regularly provide ENC for newborns and take opportunities to counsel the mothers about ENC during pregnant mothers meeting and MCH services sessions.

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Globally, as mortality among children under five declined, deaths among these children are more and more concentrated in the first days of life. These makes focus on newborn care more critically than ever before [ 1 ]. In 2018, an estimated 2.5 million children died in their first month of life, which is approximately 7000, newborns every day, with about a third of all neonatal deaths occurring within the first day after birth, and close to three-quarters occurring within the first week of life [ 2 , 3 ].

Sub-Saharan Africa had the highest neonatal mortality rate in 2019 at 27 deaths per 1000 live births, followed by Central and Southern Asia with 24 deaths per 1000 live births. A child born in sub-Saharan Africa or in Southern Asia is ten times more likely to die in the first month than a child born in a high-income country. The majority of neonatal mortality in developing countries are related to the conditions of labor, intrapartum, and poor immediate newborn care practices [ 4 , 5 ]. More than 60% of infant and 40% of under-five deaths in Ethiopia are neonatal deaths [ 6 ]. Hence, the Ethiopian government will have huge work for curbing neonatal and child mortality.

To elaborate the, WHO has stated that, “a customary practice that reduces newborn morbidity and mortality has been identified as indispensable and these include essential newborn care.” Essential newborn care (ENC) is defined as a strategic approach planned to improve the health of new-born through interventions before, during, and after pregnancy, immediately after birth, and during the postnatal period [ 7 , 8 ]. Enhancing neonatal survival begins with upgrading the health status of their mothers. It is a cost-effective intervention that improves both maternal and neonatal health as well as their nutritional status. Cord care, neonatal feeding, and thermal care are the recommended essential newborn care practice by mothers at home during the postnatal period for all new-born babies [ 7 , 8 , 9 ].

Essential newborn care (ENC) is a set of benchmark every neonate warrant regardless of where it is born. It is designed to protect the newborn from an adverse environmental condition [ 10 , 11 , 12 , 13 ]. Surveys conducted in Ethiopia indicated the prevalence of essential newborn care practice range from 11.7–65.1%. Women’s age, education, residency, economic status of women, health facility accessibility, occupation, parity, women knowledge on essential newborn care practice, counseling during the perinatal period, ANC attending and getting immediate postnatal care were among the factors associated with essential newborn care practice [ 14 , 15 , 16 , 17 , 18 , 19 ].

In Ethiopia, the health extension program is the most important community-based newborn care (CBNC) packaging that aims to improve newborn survival. This includes applying a newborn care package along with the continuum of care from pregnancy to post-partum period through frontline community workers, such as improving sepsis management [ 10 ]. Although the essential newborn practice is effective and has been widely promoted, data on women’s practice and it’s contributing factors towards essential newborn care in a study setting is limited. Therefore, this study is aimed to assess the essential newborn care practice of mothers and associated factors in Gurage Zone, Southwest Ethiopia.

Study setting, period, and design

A community-based mixed study was conducted in the Gurage Zone between March to May 2020. The Gurage zone is one of the administrative zones in South Ethiopia. It has 13 Woreda and two town administrations . Wolkite town is the capital of the Gurage zone. It is found 153 km southwest of Addis Ababa, the capital of Ethiopia. According to the 2007 national household census, the Gurage zone has a total population of 1,279,646, of which 657,568 are women [ 20 ]. There are seven hospitals (five public and two non-governmental) serving the total population in the zone. Five of the hospitals in the zone are primary hospitals, and the remaining two is a general zonal hospital. All hospitals deliver comprehensive emergency obstetric care services. Additionally, 72 health centers provide basic emergency obstetric care services in the Gurage zone.

Populations

All mothers who gave birth in six months before the study period constituted the source population. Mothers who were found in selected Keble (small administrative unit in Ethiopia) comprised the study population for this study.

Eligibility criteria

All mothers who gave birth in the past six months before the study period and were residents for at least 6 months in the study area was included in this study. Those mothers who did not able to communicate with the interviewer, seriously ill, and mothers who delivered a baby died before the data collection period were excluded.

Sample size determination

The sample size for the study was calculated using Epi Info™ version 7 StatCalc function of sample size calculation for population survey at 95% confidence interval (CI), 5% margin of error, considering 44.1% of mothers had good essential newborn care practice from the related study in Nekemte city, West Ethiopia [ 12 ] and adding 10% non-response rate, a total of 416 study participants were estimated for this study. However, due to the design effect, the final sample used for this study was 624. The design effect of 1.5 was used to calculate the sample sizes. For the qualitative part of the study, three focus group discussions (FGD) with ten mothers in each group were involved depending on idea saturation.

Sampling procedure

For quantitative data, a multi-stage sampling method was used. Purposive sampling was used for the qualitative data. From the woreda of the zone, five woreda and one town administration were selected by a simple random sampling technique using the lottery method. Then, three kebeles from each woreda and two kebeles from Butajira town were randomly selected. Households with mothers who gave birth in the past six months before the study period were listed out from the family folder of health extension workers (HEW) and the study participants were recruited by using a systematic random sampling technique.

Data collection tools and procedure

A pre-tested, structured questioner was administered to collect quantitative data. An interview control for discussion was accustomed to collect qualitative information. The tool was developed after exhaustively reviewing different relevant kinds of literature [ 14 , 15 , 16 , 17 , 18 , 19 ]. The questionnaire comprises socioeconomic characteristics, information on maternal and child health service, mothers’ knowledge on newborn care, and neonatal danger signs. The data were collected by trained 12 diploma nurses and supervised by three BSc holder nurses who were fluent in the local language. The data collectors possessed the information by face to face interview of mothers at the household level. To generate qualitative information, an FGD was conducted. Each meeting of the FGD was tape-recorded after obtaining written and signed voluntary consent from the FGD participants. Those participants were selected by the principal investigator and the discussion was conducted until saturation of ideas occurred within the group. The discussion was moderated by the principal investigator and one other assistant (data collector) took notes and recorded all the information of the FGD.

Operational definitions

Essential newborn care practice.

The practice was reported as ‘good’ for mothers who practiced three components (safe cord care, optimal thermal care, and good neonatal feeding) appropriately while the practice was reported ‘poor’ if at least one component was missed from three components.

Safe cord care

Defined as keeping the cord, clean and dry without application of any substance on the cord stump except medically indicated medications like chlorhexidine.

Optimum thermal care

A new-born wrapped in a clean, and dry cloth and delay bathing a new-born delivery for 24 h to prevent hypothermia.

Neonatal feeding

Defined as initiating breastfeeding within the first one hour after birth, giving no pre-lacteal, and feeding the child with colostrum.

Knowledge of essential new-born care

Knowledge was ‘good’ for mothers who responded greater than or equal to the mean value of knowledge-related questions correctly whereas knowledge was ‘poor’ for mothers who responded less than the mean value of knowledge-related questions.

Data quality control

To ensure quality, the questionnaire was initially drafted in the English language and then translated into the local language, Gistane by verified translators. Uttermost, before data collection, the questionnaire was back-translated into English to cinch precision. Questionnaires were pre-tested. Data were checked for completeness, accuracy, clarity, and consistency before being entered into the software. Proper coding and categorization of data were maintained for the quality of the data to be analyzed. Double data entry was used to ensure validity and compare to the original data.

Data analysis and processing

The quantitative data were coded, cleaned, edited, and entered into Epi data version 4.0.0, then exported to SPSS window version 24 for analysis. Binary logistic regression was used to assess the association between each independent variable and outcome variable. Model fitness tests were checked using a Hosmer–Lemeshow goodness-of-fit and Omnibus tests.

All variables with P <  0.25 in the bivariate analysis were included in the final model of multivariate analysis to control all possible confounders. Besides, variables that were significant in previous studies and from a context point of view were included in the final model even if the above criteria were not meet. A variance inflation factor  >  10 and standard error  >  2 were considered as suggesting the existence of multi co-linearity.

P value lees than 0.05 with 95% confidence level were used to give out statistical significance. The focus group discussion audios were initially transcribed verbatim in the local language, Gistane , and then translated into English transcripts by the principal investigator. Data were analyzed deductively by using a thematic framework analysis approach and qualitative data analysis software Open Code version 4.02 was used. Each transcript was gingerly screened and coded.

Socio-demographic characteristics

In this study, 608 participants responded to the questionnaire with a total responses rate of 97.4%. The majority of the respondents were in the age group 25–34 and the mean age of study participants were 27.38 (±4.81 SD). Of the respondents, the majority were Gurage by ethnicity 447 (73.5%) and lived in rural locations constitutes 502(82.6%). Orthodox Christianity was the dominant religion of 380 (62.5%) among study participants (See Table  1 ).

Maternal and child health services

Of the respondents, 472 (77.6%) had ANC follow-up. Two hundred two (42.8%) had one to three visits, 234 (49.6%) had four visits and 36 (7.6%) had five and more visits. During ANC follow-up the majority of 322 (53.0%) were advised about ENC. Three hundred sixty-four (59.9%) had delivered at a health institution and 354 (58.2%) had immediate postnatal care. The majority of the neonates 344 (56.6%) were male by sex and 516 (84.9%) mothers did not face any complications during delivery.

Three hundred eighty-seven (63.7%) of the study participants were assisted by a family member during the postnatal period, 113 (18.6%) of the study participants were assisted by a mother during the postnatal period, 73(12.0%) of the study participants were assisted by a neighbor during the postnatal period, and 35(5.8%) of the study participants were assisted by HEW during the postnatal period. Three hundred sixty-seven (60.4%) of the participants had given two up to four childbirth, 140 (23.0%) of the participants had given more than five childbirth and 101 (16.6%) of the participants had given one childbirth. Of the respondents, 329 (54.1%) had planned pregnancy during the last pregnancy (See Table  2 ).

Knowledge of participants about essential newborn care and neonatal danger signs

Regarding, to neonatal danger signs knowledge of participants, 294(48.4%) of them had good knowledge [who are mentioned greater than or equal to the mean value]. Furthermore, 293(48.2%) mentioned poor sucking and 387 (63.7%) mentioned fever, 234 (38.5%) mentioned difficulty of breathing, 69 (11.3%) mentioned comma, 121 (19.9%) mentioned grunt, 86 (14.1%) mentioned hypothermia, 79 (13.0%) mentioned omphalitis, 160 (26.3%) mentioned umbilical infection, 118 (19.4%) mentioned jaundice and 119 (19.6%) mentioned vomiting.

Concerning essential newborn care knowledge, 304(50.0%) of the participants had good knowledge (responded greater than the mean value of knowledge related questions). Study participants were asked about breastfeeding initiation time, bathing time, and knowledge about neonatal danger signs. Out of study participants, 253 (41.6%) stated that breastfeeding initiation time was within one hour (See Fig.  1 ).

Breastfeeding initiated time among mothers in Gurage zone, Southwest Ethiopia, 2020 ( n  = 608)

Two-hundred ninety-three (48.2%) of the study participants stated that the newborn had been bathed after 24 h post-delivery (See Fig.  2 ).

Time of bathing among mothers in Gurage zone, Southwest Ethiopia, 2020 (n = 608)

In this study, 249(41.0%) of mothers had a good practice on ENC . Of the respondents, 489 (80.4%) applied substances on the stump, 276 (56.5%) applied ointment/ powder, 181(37.0%) applied butter, 18 (3.7%) applied animal dung and 14 (2.8%) applied ash on the stump. The qualitative finding was also supplemented the quantitative one in that still there are problems in the coverage of some of the essential newborn care practice. The qualitative part particularly focused on the cord are, thermal care, and breastfeeding.

According to the opinions of most of the respondents “ The common practice reported by the discussants in the qualitative findings was the application of fresh butter on and around the stump, whether delivery occurs at home or health facility. A 19-year-old FGD discussant noted that “I delivered my first newborn three months back at home by the help of my mother. After delivery, my mother tied the cord with a thread and cut it with a new blade that I was bought from the market. To cut the cord, my mother measure from the babies’ abdomen with her fingers. If the cord was tied and cut after one finger from the abdomen of the newborn it can be dropped within one day and if tied and cut after two fingers from the abdomen of the newborn it can be dropped within two days .. ... . . During the first 7 days after delivery, I was applied fresh butter on the stump to prevent dryness and to make it soft ...”

Colostrum was given for 544 (89.5%) of the babies of respondents after delivery and pre-lacteal feeding was given for 65 (10.7%) of the babies.

Among those who gave pre-lacteal feeding 35 (53.8%) of the mothers gave plain water, 16 (24.6%) gave animal milk, 12 (18.5%) gave butter and 2 (3.1%) gave honey. A 34-year old FGD discussant mother said that “I had no antenatal care follow-up. And I was delivered at home with the help of traditional birth assistant. After delivery the attendants gave me Keneto and Tella (traditional beverage) before starting breastfeeding, they consider this would be enhanced mother breast milk and help newborns to initiate breastfeeding. Then the assistant informed me to stay for some time to breastfeed the neonate.

Four hundred sixteen (68.4%) of the newborn babies had wiped and 491 (80.8%) had wrapped the baby in cloth after delivery. Of the participants, 396(65.1%) were used to warm water at the time of bath, and 518(85.2%) had used a new cloth to wrap.

A 30 years old FGD discussant said: "I gave birth to my child four months back with the help of my mother. As soon as, the placenta was escape, she bathe me and my newborn baby with cold water. As to me, this is what all women in our community practice...." the discussant added, both I and my newborn is contaminated with dirty blood. That is why we used immediate showering (washing)....."

Four hundred nineteen (68.9%), of the participants, were used as a boiled instrument to cut the cord. Various instruments were used to cut the cord, with 376 (61.8%) respondents stating they used a new string/thread, 139 (22.9%) stating they cord tie, and 10 (1.6%) stated cord not tied.

Most of the discussants in the qualitative sentence explained that the cord was tied by thread or string and cut by a new blade if delivery occurs at home. Previously the cord was also tied apart from the Enset (Traditional plant in Ethiopia). But, the society renowned they are moving distant from this trend as improved awareness of the risks has been created by health extension workers (See Table 3 Mothers practice on essential newborn care in Gurage zone, Southwest Ethiopia, 2020 ( n  = 608) Full size table table 3 )

Factors associated with essential new-born care practices

In this study, being an urban resident, attending antenatal care visits, getting immediate postnatal care visits, attending pregnant mothers’ meetings, and having good knowledge about ENC were factors significantly associated with good essential newborn care practices.

Mothers who had urban residency were found to have a statistically significant association with essential new-born care practices. Those who had urban residency were 1.70 [AOR 1.70, 95%CI: 1.03–2.79] times more likely to practice essential new-born care as compared with those women who had a rural residency.

Mothers who had attended antenatal care visit were 3.53 times and who had attending pregnant mothers meeting were 1.86 times more likely to practice good essential newborn care, (AOR = 3.53, 95%CI: 2.14–5.83) and (AOR = 1.86, 95%CI: 1.21–2.86) respectively. The odds of good ENC practice were 3.92 among mothers who had immediate postnatal care and 2.13 among mothers who had good knowledge about ENC, (AOR = 3.92, 95% CI: 2.65–5.78) and (AOR = 2.13, 95% CI: 1.47–3.10) respectively (See Table  4 ).

The overall good essential newborn care practice was found to be 41.0% [95%CI, 36.6–44.7]. This finding is quite low compared to what it should be. The result is vital for healthcare planners. Hence, this knowledge can be used to build relevant programs, channeling scarce resources for teaching what is needed as opposed to imparting messages that are already known.

Overall, the magnitude of essential new-born care practice was 41.0%. This is nearly similar to a study conducted in Chencha district of Ethiopia (38.4%) and Nekemte city, western Ethiopia (44.1%) [ 11 , 19 ]. This study was higher than a study conducted higher than studies conducted in Awabel District, Amhara region of Ethiopia (23.1%) and Eastern Uganda (11.7%) [ 12 , 21 ]. But, lower than two studies done in South West Ethiopia (59.5%) and Eastern Tigray of Ethiopia (92.9%) [ 14 , 22 ]. The discrepancy of these findings might be attributed to the difference in methods used and study settings, sociodemographic characteristics of the study participants, and availability and accessibility of health service infrastructures.

Attending ANC visit, attending pregnant mother meeting, knowledge of the mothers about essential new-born care practices, getting immediate postnatal care, and having urban residence were factors associated with essential new-born care practices. Those women who had accessed to ANC visits were 3.53 times more likely to practice essential new-born care as compared with those women who didn’t visit ANC at all for the current delivery. This finding is consistent with studies conducted in the Nekemte, and Chencha districts of Ethiopia [ 11 , 19 ]. The possible reason could be those mothers who visited ANC would get counseling about health prevention and promotion which is believed to increase knowledge and practice of mothers about essential newborn care [ 23 ]. The odds of practice were 1.86 among mothers who attended pregnant mothers’ meetings. This is in line with the study done in Awabel District, Amhara Region, and Chencha district Southern, Region of Ethiopia [ 11 , 12 ]. Mothers who had immediate postnatal care were 3.92 times and good knowledge about essential newborn care was 2.13 times more likely to practice essential newborn care. This is in line with studies done in Chencha southern Ethiopia, Awabel District, Amhara Region of Ethiopia, Nekemte western Ethiopia Nepal, and Bachauli and Khairahani [ 11 , 12 , 19 , 24 , 25 ]. The explanation for this is mothers who had PNC discussed and were counseled about essential newborn care with health extension workers or other health care providers and mothers who had good knowledge about essential newborn care are more likely to practice essential newborn care.

Regarding, the association of residency with essential newborn care practice in this study, those who have urban residency were nearly 1.70 times more likely to practice essential newborn care than those who have rural residency. This is in-line with the fact that women that are urban residence will have information that could assist them in making decisions regarding healthy behaviors including maternal and child health education, and promotion specifically essential newborn care practice . Hence, women who have urban residency will have access and availability of infrastructures like mass media and others that could enable them to be aware of the benefit of ENCP. The findings of the study are consistent with the study findings from Northwest and Southeast Ethiopia [ 26 , 27 , 28 ].

This study indicated that the magnitude of essential newborn care practice was low. In nutshell, strengthen awareness creation activities on ENC by disseminating health information and developing communication strategies to promote positive behaviors both at the facility and community level. The primary health care provider should regularly provide ENC for newborns and take opportunities to counsel the mothers about ENC during pregnant mothers meeting and MCH services sessions are recommended.

Availability of data and materials

The full data set and other materials about this study can be obtained from the corresponding author on reasonable requests.

Abbreviations

Antenatal Care

Essential Newborn Care Practice

Maternal and Child Health

Postnatal Care

Statistical package for social science

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Acknowledgments

We would like to acknowledge Wolkite University College of medicine and health science for approving the research project . Furthermore, our special appreciation goes to data collectors for their genuine effort to bring reliable data. Finally, we would like to wholeheartedly acknowledge study participants without them this work could not be realized .

This research is financed by Wolkite University. The funder does not have any role in the design of the study, data collection, analysis, interpretation, writing manuscript, and decision to publish.

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Haimanot Abebe

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HA: Conceives the research idea, proposal development, supervised data collection process, conduct the analysis, and wrote the manuscript.

DA: involved in proposal development, data analysis, and wrote the manuscript.

SS: involved in data analysis, result writing, and wrote the manuscript. All authors have read, and confirmed the manuscript.

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Ethical clearance was obtained from the Wolkite University College of Health and Medical Science Institutional Health Research Ethical Review Committee with the reference number CMHS/025/2020. An official letter was sent to the Gurage health office and the data collection was begun after permission and cooperation letter was written to all districts on which the study was carried out. The study, purpose, procedure and duration, rights of the respondents, and data safety issues, possible risks and benefits of the study was clearly explained to each participant using the local language. Then, all subjects gave their informed written consent for inclusion before they participated in the study.

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Abebe, H., Adane, D. & Shitu, S. Essential newborn care practice and its associated factors in Southwest Ethiopia. Arch Public Health 79 , 42 (2021). https://doi.org/10.1186/s13690-021-00568-6

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Received : 03 December 2020

Accepted : 22 March 2021

Published : 31 March 2021

DOI : https://doi.org/10.1186/s13690-021-00568-6

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• Published: 21 September 2022

Effectiveness of early essential newborn care implementation in four counties of western China

• Chenran Wang 1 ,
• Yun Lin 1 ,
• Hanxiyue Zhang 2 ,
• Ge Yang 2 , 3 ,
• Kun Tang 2 ,
• Xiaobo Tian 4 ,
• Xiaona Huang 4 &

BMC Health Services Research volume  22 , Article number:  1185 ( 2022 ) Cite this article

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Neonatal survival is a public health concern globally. However, the regional disparity in neonatal mortality between rural counties of western China and urban areas of eastern provinces remains high. Early essential newborn care (EENC), recommended by World Health Organization, refers to a set of cost-effective interventions to improve neonatal health and development outcomes. In this study, we aimed to explore the effectiveness of EENC implementation in four counties of western China.

Pre- and post-intervention investigations were conducted in four selected EENC intervention counties and four control counties of four western provinces of China, from June to August 2017 and from December 2020 to April 2021 respectively. A mixed quantitative and qualitative approach was used for data collection and analysis. Data on the coverage of EENC practices were collected via a post-intervention face-to-face questionnaire survey with postpartum mothers before hospital discharge. Hospital-reported data on neonatal health indicators were obtained through mail surveys in both investigations. We also performed semi-structured interviews with policymakers, health staff and postpartum mothers to understand their perceptions about the usefulness of EENC implementation.

Overall, 599 mother-newborn pairs in the intervention group and 699 pairs in the control group participated in the post-intervention survey. Controlling for the confounding factor of province, the proportion of newborns receiving EENC interventions was higher in the intervention group than in the control group ( P  < 0.05). Intervention groups in four provinces had higher coverage of: any skin-to-skin contact (99.50% vs. 49.07%); early breastfeeding initiation (within 60 min of birth) (90.84% vs . 80.35%); no medicine applied to the umbilical cord (98.50% vs. 9.73%); routine eye care (93.16% vs. 8.73%); and vitamin K 1 administration (98.33% vs. 88.98%). EENC implementation was associated with decreased risk of neonatal diarrhea ( OR : 0.326, 95% CI : 0.123, 0.865) and eye infection ( OR : 0.147, 95% CI : 0.045, 0.483). Policymakers, health staff and postpartum mothers expressed satisfaction with the EENC interventions, noting a willingness among staff and policymakers to implement and sustain these interventions; the promotion of these interventions within hospital policy; the positive emotions experienced by postpartum mothers; perceived improvements in health; and improvements in support for health workers.

EENC-recommended core practices (except kangaroo mother care) have been successfully introduced in pilot hospitals. The efficacy of EENC implementation should be highly recognized to accelerate the progress towards its national roll out.

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Introduction

Neonatal health care is critical to child short- and long-term survival and development; ensuring a healthy start for all newborns will accelerate progress towards the Sustainable Development Goal (SDG) target of “ending preventable deaths of newborns by 2030” [ 1 , 2 ]. While significant progress has been made in addressing child survival, neonatal death remains a serious concern globally, accounting for approximately 48% of all deaths among children under 5 years of age. More than two-thirds of neonatal deaths occur in the first three days after birth, especially in first 24 h after birth [ 3 , 4 ]. China has reduced the rate of neonatal mortality from 33.1‰ in 1991 to 3.4‰ in 2020, however, newborn death is still the leading contributor to under-5 mortality [ 5 ]. Furthermore, the regional disparity in neonatal mortality between rural counties of western China and urban areas of eastern provinces remains high. The national report of China Maternal and Child Health Surveillance in 2020 showed that the neonatal mortality rates in western (4.8‰) and rural (3.9‰) regions were notably higher in comparison to eastern (1.8‰) and urban (2.1‰) areas [ 5 ]. The regional discrepancy in the burden of newborn deaths can be partly explained by the coverage inequality of high-quality newborn interventions across regions [ 6 , 7 ]. Therefore, adopting effective interventions to address these discrepancies should be a high national priority.

Early Essential Newborn Care (EENC) is a package of evidence-based interventions for mothers and newborns delivered around birth. It was recommended by World Health Organization (WHO) Action Plan for Healthy Newborn Infants in the Western Pacific Region (2014–2020) to reduce preventable newborn deaths [ 8 ]. EENC emphasizes the minimization of unnecessary practices, such as routine suctioning and early physical examination for newborns, while promoting core cost-effective practices, including: immediate and uninterrupted mother-baby skin-to-skin contact (SSC) for at least 90 min, delayed umbilical cord clamping, early breastfeeding initiation, and kangaroo mother care for premature infants [ 9 , 10 ]. All priority countries in the Western Pacific Region have continued to scale up EENC and the applicability of EENC has been substantiated in other countries [ 11 ]. To sustain these advancements, additional efforts are needed to integrate EENC into routine clinical practice.

With the aim of achieving equitable and high-quality coverage of health care for all newborns, the National Health Commission of China and the United Nations Children’s Fund (UNICEF) jointly launched the three-year Safe Neonatal Project in western China. From September 2017 to December 2020, the project was implemented in 18 counties of four western provinces with the highest burden of neonatal and under-5 deaths, including Qinghai, Sichuan, Guizhou, and Ningxia Hui Autonomous Region [ 7 ], setting out a vision of a nation where every newborn reaches his or her full potential. The purpose of the Safe Neonatal Project is to scale up EENC interventions in pilot counties; it aims to ensure that mothers and newborns in pilot areas increasingly benefit from equitable policies, guidelines, and quality, high-impact EENC practices for survival and development.

Understanding the health effects of EENC implementation is necessary to scale up EENC nationally. Evidence has indicated that EENC-recommended interventions are practical and cost-effective for improving neonatal health outcomes in western China [ 12 , 13 ]. However, previous studies on EENC implementation were restricted to pre- and post-intervention design within groups [ 13 , 14 ]; used only cross-sectional observational investigation of service capacity [ 15 ]; employed a narrow research scope with small sample size [ 16 , 17 ]; and conducted limited qualitative research that lacked the perspectives of multiple stakeholders [ 18 , 19 ]. Moreover, most studies lacked controls and a multi-centre design [ 13 , 14 , 16 ]. Our large sample, multi-centre study, is an attempt to address the above noted gaps in research to date. Based on data obtained from the Safe Neonatal Project, we aim to comprehensively explore the positive impacts of EENC implementation. Our findings will provide empirical references on the clinical practice of EENC to China and other countries with similar demands, with the goal of informing health authorities how tailored EENC promotion strategies can enhance neonatal health and well-being.

Study design

This was a pre- and post-intervention study. Data were collected from baseline and endline investigations, which were conducted from June to August 2017, and from December 2020 to April 2021, respectively. We conducted mixed quantitative and qualitative analyses to assess the positive impacts of EENC implementation.

Study settings

Out of the 18 Safe Neonatal Project counties, one county was randomly selected as the intervention county in each province in our study, with a control county being selected from the same province. In each intervention/control county, one to two county-level hospitals providing midwifery services with over 1000 live births annually were selected as sample health facilities. A total of 15 health facilities were enrolled in this study, with seven in the intervention group and eight in the control group, respectively. The province-stratified group allocation and on-site survey time are shown in supplementary table 1 . The two groups were homogeneous in socioeconomic development, demography, and maternal and child health care levels [ 20 , 21 ].

EENC implementation

Eenc practices.

EENC contains a package of evidence-based interventions for maternal and neonatal health improvement. The seven key practices are as follows:

Within 1 min after birth:

Neonatal resuscitation for newborns if without spontaneous breathing.

Immediate and prolonged SSC: The thoroughly dried neonate is in direct skin contact with mother’s bare breast and abdomen for ≥ 90 min. Cover (do not wrap) the newborn’s skin with clean warm cloth and the head with a hat.

Within 1–3 min of birth:

Delayed umbilical cord clamping and proper care: Umbilical cord clamping is delayed until there is no umbilical pulsation. No sterilization medicines are applied to the cord stump.

Within 90 min of birth:

Early breastfeeding initiation: Initiating early breastfeeding when baby presents feeding cues, including rooting, tonguing or biting hands. Baby latches on and stays fixed to the nipple, opening mouth widely to attach to mother’s breast and sucking successfully.

Kangaroo mother care for premature and low birthweight infants: Preterm newborns with gestational age ≤ 34 weeks or low birthweight newborns with birth weight ≤ 2000 g is placed in continuous SSC between his/her mother, father or other family members.

90 min to 24 h after birth:

An intramuscular administration of 1 mg vitamin K 1 to prevent neonatal hemorrhagic diseases.

Routine eye care with erythromycin to prevent neonatal eye infection.

Out of the core interventions, sustained SSC for ≥ 90 min, early breastfeeding initiation within 60 min after birth, no medicine applied to umbilical cord, routine eye care, and vitamin K 1 administration were selected as key indicators to assess the general coverage of EENC practices in this study. Before EENC introduction in pilot counties, vitamin K 1 administration had already been implemented in some of the enrolled health facilities.

Intervention group

EENC was introduced to the intervention counties through cascading coaching carried out through certified national and provincial facilitators. The coaching process strictly adhered to WHO Early Essential Newborn Care Module 2—Coaching for the First Embrace—Facilitator’s Guide [ 22 ]. Subsequently, the trained multidisciplinary team that was composed of obstetricians, midwives, pediatricians/neonatologists, nurses, and hospital administration (including infection control and quality assessment) staff implemented EENC-recommended practices following the publicly-published national expert consensus [ 23 , 24 ].

The quality assessment of EENC implementation was carried out quarterly by national and provincial facilitators, in order to oversee the execution of EENC and ensure that all trained staff grasped the skills. Self-assessments of routine newborn care practices were recorded periodically by quality control teams of health facilities, and the assessment tools were formulated based on WHO Early Essential Newborn Care Module 3—Introducing and sustaining EENC in hospitals: routine childbirth and newborn care [ 23 ].

Control group

Non-recommended routine newborn health care practices, including immediate mother-newborn separation and umbilical cord clamping, cord wrapping, and application of disinfectant to the cord, were implemented in the control hospitals. Of note, EENC will be introduced to the control group when the study ends.

Sample size estimation

Postpartum mother-newborn pairs.

In the post-EENC phase, we conducted the questionnaire survey with postpartum mothers and their newborns before hospital discharge. Postpartum mothers and their newborns were selected based on the following criteria: 1) postpartum mothers agreed to participate this study with written informed consent; 2) mothers delivered vaginally at least two hours prior to questionnaire interviews; 3) mothers had not experienced a stillbirth or newborn death. Postpartum mothers who were multiparous were excluded to avoid duplication in data collection. The sample size of mother-newborn pairs was calculated using the following formula:

The proportion of early breastfeeding initiation was selected as the core indicator for estimating the sample size, where P 1 is the proportion of early breastfeeding initiation (within 1 h after birth) before EENC implementation, and P 2 is the proportion of early breastfeeding initiation after EENC implementation, and P is \(\frac{{P_{1} + P_{2} }}{2}\) , and Z 1 - α/2 / Z β is standard normal deviance at the significance level of α /1- β.

We assumed P 1 at baseline of 40% based on previous literature [ 25 ]. EENC implementation was expected to increase P 1 by 20% and thus P 2 was estimated as 60%. A minimum sample of 148 ( α  = 0.05; β  = 0.10) mother–child pairs per group was therefore calculated with allowance for 15% invalid samples. The theoretical minimum sample size of mother-newborn pairs was 1184 (group*stratified province = 148*2*4).

Considering that the recruited hospitals from the geographically dispersed and health resource-limited western counties tended to have a low delivery volume annually, we enrolled all mother-newborn pairs fulfilling the enrollment criteria during the investigation, with the aim of ensuring an adequate sample size.

Interested stakeholders

During the endline investigation, we conducted semi-structured focus group discussions with policymakers and health staff, and individual in-depth interviews with postpartum mothers in each group of the eight counties, as they represented different roles of stakeholders regarding the EENC intervention. National policies, WHO EENC modules, and relevant literature were reviewed to help synthesize interviews. We performed purposive sampling to recruit participants and the sample size was determined as per data saturation.

Data collection

Mail survey for health facilities.

Mail surveys were conducted in all 15 enrolled health facilities to review the impact of EENC on newborn health indicators before and after implementation. The mail survey questionnaire was designed based on WHO Early Essential Newborn Care Module 1- Annual implementation review and planning guide. It collected neonatal health indicators in the past 12 months, which were recorded by directors of obstetrics or neonatology/pediatrics based on routine monitoring records of the recruited health facilities. The same electronic questionnaires were issued by the National Health Commission of China at both baseline and endline phases, while data submission was overseen and verified by hospital quality control teams. Health indicators of interest included neonatal diarrhea, umbilical infection, eye infection, and mortality during the neonatal period (0 ~ 28 days).

Questionnaire survey for mother-newborn pairs

The questionnaire for postpartum mothers and newborns was designed in reference to the WHO Early Essential Newborn Care Module 3 [ 19 ] and focused on coverage indicators of EENC key practices. Specifically, data on SSC and breastfeeding practices were obtained from face-to-face questionnaire interviews with postpartum mothers, while coverage on practices of umbilical cord and routine eye care, and vitamin K 1 administration were extracted from neonatal medical records. The contents of questionnaire survey were documented by midwives, obstetric nurses and doctors.

Qualitative survey with interested stakeholders

The qualitative survey focused on the knowledge of EENC, adherence to the EENC-recommended practices, and target populations’ satisfaction of EENC implementation. All interviews were conducted in quiet and private rooms to enable stakeholders to provide subjective assessments of EENC implementation according to their experiences. Every focus group discussion and in-depth interview lasted for approximately 90 min and 30 min, respectively. All participants involved in interviews provided written informed consent.

Neonatal health indicators of interest

The effectiveness of EENC implementation was evaluated by the quantification of differences in core practices coverage and neonatal health indicators (neonatal diarrhea, umbilical infection, eye infection, and mortality during the neonatal period) between intervention and control groups, and perceived usefulness of the interventions obtained from interested stakeholders.

Data analysis

Data obtained from mail surveys and questionnaire surveys were in institutional and individual level forms, respectively. As our study was conducted in four provinces, stratification by province was performed to control the potential regional variation. We did descriptive analyses of demographic characteristics of postpartum mothers and babies with frequency (proportion) and mean ± standard deviance (SD). Cochran-Mantel–Haenszel (CMH) test/Fisher exact probability method for categorical variables and t -test for quantitative data, with the confounding factor being controlled for, were carried out to test the significance of differences between intervention and control groups. We used 95% confidence intervals ( CI ) to estimate the uncertainty in differences of EENC practices coverage between the two groups. Unconditional logistic model was used to examine the association between EENC implementation and neonatal health indicators. Participants with missing data for key variables were removed. Data were put into EpiData 3.1 with double-entry method, and SAS 9.4 (SAS Institute Inc., Cary, NC, USA) was used to conduct statistical analyses. The significance level of α was 0.05.

All interviews were audio-taped and the recordings were transcribed into textual materials. The thematic framework approach was used to analyse qualitative data. Perspectives of multiple stakeholders (i.e., policymakers, health staff and postpartum mothers) on each thematic category were generalized and presented for mutual authentication. The four stages of data analysis were: [ 26 ] (1) familiarization with transcripts; (2) identification of a thematic framework; (3) data coding; and (4) interpretation of main findings. QSR Nvivo 12.0 was used for data generalization and numerical coding.

Demographic characteristics of mother-newborn pairs

A total of 1373 questionnaires of mother-newborn pairs were collected in the endline survey, of which 75 were invalid due to inappropriate subjects, and excessive missing items or logic errors. Finally, we enrolled 1298 mother-newborn pairs from eight counties in the four provinces, with 599 pairs in the intervention group and 699 pairs in the control group. With the confounding factor of province being controlled for, no statistically significant differences were found in the distribution of maternal age and neonatal birthweight ( P  > 0.05). Pregnant women in the intervention group had an average age of 26.11 ± 5.44 years, and 383 (63.94%) had an educational attainment of junior high school or lower; postpartum mothers in the control group were aged 26.33 ± 5.18 years and 423 (60.52%) had junior high school level education or lower. Newborns enrolled in the intervention and control groups had mean birth lengths of 49.59 ± 1.76 cm and 50.33 ± 1.71 cm, with 570 (95.16%) and 653 (93.42%) weighing 2500 ~ 4000 g, respectively. Demographic characteristics of recruited mother-newborn pairs were shown in Table 1 .

Coverage of EENC core interventions

Before the introduction of EENC, other key clinical practices were not performed in both intervention and control groups (with the exception of vitamin K 1 administration, which had been implemented in some of the enrolled health facilities). All practices, except for kangaroo mother care, were implemented in intervention counties after EENC implementation. SSC and routine eye care were partly implemented in control groups (Fig.  1 ).

Clinical practices of EENC core interventions (except for kangaroo mother care)

With the confounding variable of province being controlled for, compared with the control group, significant improvements in proportions of neonates receiving all selected EENC core practices were noted in the intervention group at end line ( P  < 0.05). The disparities in practice coverage between the two groups were homogeneous in four provinces. Intervention groups in four provinces had higher coverage of immediate SSC (within 1 min) (85.07% vs . 21.87%); prolonged SSC for at least 90 min (78.02% vs . 0.58%); early breastfeeding initiation (within 60 min) (90.84% vs . 80.35%); and exclusive breastfeeding before discharge (92.57% vs . 63.80%). Coverage was particularly high in Guizhou Province: 92.62% for immediate SSC; 90.60% for prolonged SSC; 97.98% for early breastfeeding initiation; and 95.30% for exclusive breastfeeding. In the intervention groups, no applied medicine to the umbilical cord (98.50% vs . 9.73%), routine eye care (93.16% vs . 8.73%), and intramuscular injection of vitamin K 1 (98.33% vs . 88.98%) were common (> 90%), except for routine eye care in Ningxia Hui Autonomous Region (Table 2 ).

More babies in the intervention group versus control group received five EENC practices post intervention, with the difference in coverage between the two groups being 67.45% (95% CI : 63.69%–71.20%). Differences in the proportion of newborns receiving all five practices between two groups in Guizhou, Qinghai, Sichuan and Ningxia were 85.33% (79.67%–90.99%), 72.99% (65.56%–80.43%), 74.34% (67.40% ~ 81.29%), and 39.38% (31.80%–46.95%), respectively (Fig.  2 ).

Difference in general coverage of EENC core interventions between intervention and control groups according to endline survey

The differences in coverage of EENC practices between the two groups in detail were shown in supplementary Figs. 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , and supplementary Table 2 .

Neonatal health indicators

The univariate logistic regression model showed that EENC implementation was associated with decreased risk of neonatal diarrhea ( OR : 0.327, 95% CI : 0.123, 0.867) and eye infection ( OR : 0.147, 95% CI : 0.045, 0.483). After controlling for the confounding factor of province, similar results were found in association between EENC and decreased risk of neonatal diarrhea ( OR : 0.326, 95% CI : 0.123, 0.865) and eye infection ( OR : 0.147, 95% CI : 0.045, 0.483). The result was not powered enough to detect the potential association between EENC implementation and neonatal mortality and umbilical infection (Table 3 ).

EENC satisfaction of stakeholders

183 participants recruited from eight counties were interviewed, consisting of 52 policymakers (25 in the intervention group and 27 in the control group); 94 health staff members (45 in the intervention group and 49 in the control group); and 37 postpartum mothers (15 in the intervention group and 22 in the control group). The sample size of interviewees recruited in each group stratified by province is reported in supplementary Table 3 .

The satisfaction level of interested parties was summarized into six sub-themes: recognition, policy, emotion, work support, health outcomes, and sustainability (see supplementary Fig.  12 ). Most stakeholders stated that EENC had been widely recognized. The positive health effects of EENC practices promoted the implementation of policies relevant to newborn health care at the county and hospital levels. SSC brought great happiness to mothers and helped them bond with their newborns. Health staff stated that the EENC coaching improved their professional skills and promoted the normalization and standardization of clinical practices. Notably, some participants believed that EENC implementation was associated with reduced incidence risk of neonatal hypothermia, umbilical cord infection and neonatal mortality. Because EENC brought direct health benefits to health workers, mothers, and neonates, most policymakers clearly expressed their commitment to continue to implement EENC-recommended interventions. Selected quotes from stakeholders regarding satisfaction with EENC interventions are reported in Table 4 .

To the best of our knowledge, this is the first and largest study to investigate the coverage and health effects of EENC practices in western China. According to our present study, a considerably higher coverage of EENC key practices, including immediate and prolonged SSC, early breastfeeding initiation, no medicine applied to the umbilical cord, eye care, and vitamin K 1 administration, was observed in intervention hospitals in the post-EENC phase. Furthermore, we found that compared with our interim evaluation in the same provinces [ 13 ], the proportions of newborns receiving EENC key practices increased (SSC duration ≥ 90 min: 63.1% vs .78.0%; any breastfeeding: 96.1% vs . 96.7%; vitamin K 1 administration: 79.7% vs . 98.3%; newborn eye care: 58.4% vs . 93.2%), which indicates the successful EENC promotion in pilot counties. However, kangaroo mother care for preterm newborns was not implemented in intervention hospitals due to limited technical support in western counties. These findings provide important information for optimizing EENC practices further in poverty-stricken areas of western China, and potentially in other high-demand areas of the world.

Our study showed that mother-newborn SSC was associated with increased proportions of early initiation breastfeeding and a longer duration of first-breastfeeding – findings that are highly consistent with previous studies [ 27 , 28 ]. SSC may activate the oxytocinergic system, and the elevated concentration of oxytocin in postpartum mothers in turn promotes lactation and prolonged breastfeeding duration [ 29 ]. In response to the WHO recommendation to “ facilitate immediate and uninterrupted skin-to-skin contact and support mothers to initiate breastfeeding as soon as possible after birth ”, advocated as part of the Baby-Friendly Hospital Initiative [ 30 ], SSC should be steadily facilitated to provide optimal breastfeeding support and high-quality services for mothers and newborns. Additionally, we found that SSC was a positive experience for most postpartum mothers that improved mothers’ satisfaction, breastfeeding confidence, and mother–child bonding. As WHO indicates, high-quality health care can encourage mothers to adopt pro-health behaviours [ 31 ]. Further, in Viet Nam, some private hospitals regarded EENC as a special service that attracted pregnant women seeking high-quality antenatal and childbirth care [ 18 ]. To optimize the experience of postpartum mothers and improve the quality of health services, efforts should be taken to make SSC available to all mothers and neonates.

The usual practices of clamping the umbilical cord immediately after birth and applying disinfectant to the cord can increase the risk of bacterial infection [ 22 ]. The guideline released by WHO in 2014 indicated that, for improved maternal and child health outcomes, umbilical cord clamping should be delayed until there is no cord pulsation [ 32 ]. Indeed, a quasi-experimental study in China found that newborns receiving EENC interventions experienced lower umbilical cord infection rate compared to those in control groups (0.3% vs . 0.9%) [ 33 ]; however, no significant health effect was found in our study. Even though the proportion of newborns receiving no applied medicine to the umbilical cord was high in pilot hospitals, the lower umbilical infection rate (0.43% vs . 0.00%) was observed merely in pilot hospitals of Sichuan Province. The undetected health effects in other centres may be partly explained by the imperfect quality of hospital-reported data, which highlights the need for more stringent quality control measures and routine health management in pilot health facilities.

WHO-recommended routine eye care and vitamin K 1 administration should be applied to prevent neonatal ophthalmia and haemorrhage [ 34 , 35 ], and the health benefits of this practice have been reported in previous publications [ 35 , 36 , 37 ]. Although the overall eye infection rate in the intervention group was found lower than the control counterpart (0.04% vs . 0.29%), further studies with longer observation period and more rigorous quality supervision are needed to strengthen the evidence base.

Normalization Process Theory provides a theoretical framework for assessing the probability of routine embedding of complex interventions: when practitioners acknowledge the importance and benefits of new interventions, the new routine is expected to be sustainable [ 38 ]. Consistent with Normalization Process Theory, we observed that the positive feedback from postpartum mothers and improved neonatal health indicators convinced health staff of the value of EENC, which in turn motivated them to routinely implement EENC- recommended practices. Our findings contribute to the growing evidence for introducing these effective practices into primary health facilities.

Nevertheless, previous studies have noted the lack of national technical guidelines for newborn care in China, which have caused inconsistencies in childbirth and early newborn care practices across regions [ 39 ]. As such, it is anticipated to be an uphill battle to scale up EENC nationwide in China. Moreover, Frederick AC et al. revealed that health staff shortages were also perceived as a challenge to the implementation of EENC practices in our pilot hospitals, leading to interruptions in health worker support for sustained SSC. [ 18 , 40 ] Since regional disparities between western rural counties and urban areas in economically developed provinces in China remain high, the allocations in equipment supplied to western health facilities should be increased (e.g., maternity wards, radiant warmers, and neonatal resuscitation equipment) [ 41 , 42 ]. In our present study, most postpartum mothers had junior high school or lower education. Current evidence suggests that education level can be one of the most important socioeconomic factors in gaining access to EENC practices. Better access to education may be associated with the increased availability of high-quality health services, while the health behaviours of poorly educated mothers were easily affected by their surroundings [ 43 , 44 ]. Therefore, increased investment in timely and effective promotion of EENC, such as the provision of accessible health educational materials, should be positioned as a priority for poorly educated pregnant women and their family members in poverty-stricken or geographically distant areas.

This is the first study to evaluate the effectiveness of EENC implementation through various data sources and mixed quantitative and qualitative methods. By introducing the control group, our findings indicate that EENC implementation is associated with improved health status of neonates, and the differences in core practice coverage between groups needed to be considered in the further scale-up of EENC. Our results can be regarded as a valuable reference on further promotion of EENC in China and other countries with a similar context. Compared with previous studies with pre- and post-intervention design, the control group was set in our study to better assess the improvement of EENC core intervention coverage and health indicators. Considering the potential regional variation across four western provinces, we conducted stratification analyses, controlling for the confounding variable of province. Moreover, the extraction of some EENC key coverage indicators from neonatal medical records helps to alleviate observation bias (i.e., the Hawthorne effect). Notably, we collected assessments of multiple stakeholders, including policymakers, health staff, and postpartum mothers on each thematic category, which provided mutual authentication across different roles. In our study, the quantitative and qualitative results validated and complemented each other, which enhanced the validity of our findings.

This study has some limitations. Firstly, we collected questionnaire data on postpartum mothers and newborns from county-level hospitals with relatively large delivery volumes, thus the findings might not be generalizable to health facilities of other levels and provinces. Secondly, as data on SSC and breastfeeding practices were reported by postpartum mothers, recall bias may affect the precision of coverage indicators. Thirdly, the efficacy of EENC interventions may be underestimated if obstetrical health staff in control groups attended EENC-relevant technical training during the EENC implementation period. Finally, due to the unavailability of individual cases on health indicators, we could not link reported EENC practices with neonatal health impacts. The casual association between EENC practices and neonatal health impacts is worthy of further exploration.

EEEC practices are feasible and have been successfully introduced to intervention hospitals of western China. EENC core interventions (except for kangaroo mother care) are routinely implemented in pilot health facilities, and the implementation is associated with reduced incidence risk of neonatal diarrhea and eye infection. The perceived usefulness of EENC interventions was identified by multiple stakeholders, who noted the willingness of staff to implement these interventions, the promotion of these interventions within hospital policy, the positive emotions experienced by postpartum mothers, and improvements in work-related support for health workers. The potential obstacles to EENC implementation mean concerted efforts should be made in China to meet the WHO target “at least 80% of facilities providing childbirth services implementing EENC”.

Availability of data and materials

The datasets supporting the conclusions of this article are available from the corresponding author on reasonable request.

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We are truly grateful to all mothers, newborns, policymakers, and health staff participating in this study.

The present study was supported by Safe Neonatal Project of the UNICEF Office for China.

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The research was designed by TX and XBT. The data analysis and draft of the manuscript were completed by CRW. The on-site data were collected by CRW, YL, HXYZ, and GY. The data supervision and quality control were done by TX, YL, XBT, and CRW. TX, XNH, and XBT helped with the draft revision. All authors approved the final manuscript as submitted and agreed to be accountable for all aspects of the work.

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Wang, C., Lin, Y., Zhang, H. et al. Effectiveness of early essential newborn care implementation in four counties of western China. BMC Health Serv Res 22 , 1185 (2022). https://doi.org/10.1186/s12913-022-08570-6

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Essential Newborn Care and Associated Factors Among Obstetrical Care Providers in Awi Zone Health Facilities, Northwest Ethiopia: An Institutional-Based Cross-Sectional Study

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Authors Ayenew A , Abebe M , Ewnetu M

Received 13 August 2020

Accepted for publication 16 October 2020

Published 11 November 2020 Volume 2020:11 Pages 449—458

DOI https://doi.org/10.2147/PHMT.S276698

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Asteray Ayenew, 1 Mahlet Abebe, 2 Mesafint Ewnetu 1 1 Department of Midwifery, School of Health Sciences, College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia; 2 Department of Midwifery, School of Health Sciences, College of Medicine and Health Sciences, Mizan Tepi University, Mizan Teferi, Ethiopia Correspondence: Asteray Ayenew Email [email protected] Background: Each year, millions of newborns die as a result of birth asphyxia, infections, and complications of preterm birth. This burden of death is disproportionately concentrated in low-income countries including Ethiopia. As a result, the care given immediately after birth is crucial for making a successful transition from intrauterine to extrauterine function and to reduce neonatal mortality. Methods: Facility-based cross-sectional study design was carried out on a sample size of 208 obstetrical care providers. A simple random sampling technique was used to select the study subjects. The data were collected through Interview-administered questionnaires and observational checklists. The data were entered into Epi-info version 7 and exported to SPSS 23 for analysis. Results: A total of 201 obstetric care providers participated in the study, making a response rate of (96.6%). This study revealed that 62.7% of obstetric care providers practiced essential newborn care properly. The factors significantly associated were received in-service training (AOR = 2.7, 95% CI: 1.35, 5.51), level of education (AOR = 0.46, 95% CI: 0.22, 0.96), midwifery profession (AOR = 3.1, 95% CI: 1.35, 7.39), having good knowledge of essential newborn care (AOR = 2.1, 95% CI: 1.03, 4.49), availability of drugs for essential newborn care (AOR = 2.3, 95% CI: 1.16, 4.72), and availability of medical equipment to perform essential newborn care (AOR = 2, 95% CI: 1.01, 3.96). Conclusion: The practice of essential newborn care was generally low. Having in-service training, midwifery profession, a good knowledge of essential newborn care, availability of drugs, level of education, and availability of medical equipment for essential newborn care were the determinant factors for essential newborn care practice. Improvement in essential newborn care practices could be attained through modifiable proven interventions like provision of in-service training, availed drugs, and medical equipment for essential newborn care. Keywords: essential newborn care, obstetric care providers, Ethiopia

Essential newborn care is the care provided to the neonate after birth within the delivery room by skilled personnel which includes drying and stimulating, assessing breathing, cord care, skin to skin contact, initiating exclusive breastfeeding, eye care, vitamin k provision, place of identification band and weighing. 1

Birth is the main challenge for the newborn to settle successfully from the maternal womb to extrauterine life. The first few hours after birth are the most basic period in the life of an infant for better growth and development 2 at which obstetric care providers have a significant role. 3 Globally, every year 2.7 million neonates die which accounts 45%, 58%, 75% of under-5, infant, and neonatal mortality respectively. 4 , 5 Among those global neonatal deaths, neonatal deaths in low and middle income countries accounted for most of the growing proportion of all under-five mortality. 6 If the trend continues like this, the share of neonatal deaths to under-5 death is projected to increase from 45% in 2015 to 52% in 2030. 7 According to the 2016 Ethiopia Demographic and Health Surveys (EDHS) report, the infant mortality rate was 48 per 1000 live births and the neonatal mortality rate is 29 per 1000 in Ethiopia. 8

Another study conducted in Ethiopia on trends and determinants of neonatal mortality identified preterm birth, intrapartum events such as birth asphyxia, infections such as sepsis, and congenital malformations as a cause of early newborn neonatal mortality. 9

Essential newborn care interventions to protect against newborn morbidity and mortality are, by using clean cord care, thermal care including drying and wrapping of the newborn immediately after delivery and delaying the newborn’s first bath for at least 24 h (or several days to reduce hypothermia risk), and initiation of breastfeeding within the first one hour of birth, management of immediate asphyxia, management of early sepsis. 10 About 3 million lives could be saved each year with worldwide coverage of the evidence based solutions such as care during labor and around birth by skilled birth attendants. The “Every Newborn Action Plan” (ENAP) calls for an increased center of attention on the time around birth with targeted high impact interventions as a strategy for dropping not only newborn deaths but also maternal deaths and stillbirths, producing a triple return in investment. 11 Even though there has been considerable progress over the last two decades on neonatal mortality, still, poor care during delivery and immediately after birth was largely responsible for the annual deaths of an estimated 2.5 million newborns in the first month of life in 2017. 12 Generally, Ethiopia, like other sub-Saharan countries, has a high perinatal mortality and, specifically, the area of study Amhara regional state (Awi zone) is the first region with a high burden of perinatal mortality and stillbirth from all regional states of Ethiopia according to EDHS 2016.

Children who die within the first 28 days of birth suffer from circumstances, diseases of birth, and in the first days of life. Quality skilled care at birth would make certain that the newborn receives essential newborn care including drying and stimulating, assessment of breathing, cord care, skin to skin contact, early breast feeding, vitamin k provision, labeling, and weighing properly. 13

Proper essential care of a newborn is significantly important for survival, growth, and development of a newborn. 3 Little is known about practice and factors associated with the practice of essential care of the newborn in Ethiopia. As a result, this study aimed to assess the practice of essential newborn care and its associated factors among obstetrical care providers in the Awi zone, northwest Ethiopia, to develop effective strategies to promote care and baseline for further research.

Study Design and Study Participants

The facility-based cross-sectional study design was used in the governmental public health facilities of Awi Zone. The study period was from March 1 to April 15, 2019. The source population was all obstetrical care providers in the Awi zone who were working in the study area and the study population was all selected obstetrical care providers from the selected health facilities.

The study was conducted in the Awi zone, Amhara region, northwest Ethiopia. It is located 449 km from Addis Ababa, the capital city of Ethiopia, and 114 km from Bahir Dar, the main city of the Amhara region. The zone is bordered on the west by the Benishangul–Gumuz Region, on the north by the North Gondar zone, and on the east by West Gojjam. Based on the 2007 census data, conducted by the Central Statistical Agency, the Awi zone has a total population of 1,220,316 in 2016, of whom 598,880 (49.1%) are men and 621,436 (50.9%) are women. 14 In the zone there are 46 health centers and 5 hospitals that provide labor and delivery service for the community. Midwives, nurses, public health officers, and IESO are responsible for attending labor and delivery services and essential newborn care services in the zone. The zone had 496 obstetric care providers, and the annual institutional delivery of 25,606 attended by those obstetric care providers.

Sample Size and Sampling Procedure

Assumptions: n = required sample size,

Z a/2 = critical value for normal distribution at 95% confidence interval (1.96),

P = 72.77% proportion of practice of essential new born care among health care providers taken from the study conducted in the eastern zone of the Tigray region, 15

d = 0.05 (margin of error).

Where, nf = final sample size,

n = initial sample size,

N = source population (obstetric care provider).

Finally, by adding 10% to the sample size for non response rate, the total of 208 individuals were included in the study.

There are nine woredas in the Awi zone, and six were selected by the lottery method. All public health facilities found in the selected woredas were included in the study. Then, the calculated sample size was proportionally allocated for each health facility based on the number of obstetric care providers. Since the number of obstetric care providers in each governmental health facility is not equal, the calculated sample size allocated for each health facility was proportionally allocated to determine the number of obstetric care providers included in the study from each facility. Finally, all randomly selected obstetrical care providers who were available during the data collection period were included in the study.

Data Collection Instruments, Procedure and Quality Assurance

The data were collected through interviewer-administered structured and pretested questionnaires, and observational checklists.

The questioner and checklist were adapted from different relevant literature like the World Health Organization, Integrated Maternal Newborn care Basic skill course Learning and Evaluation checklist, and other related sources. 16–19 The structured questionnaire had three parts; socio-demographic factor with seven items, associated factors with eighteen questions, and an observational checklist containing fifteen tasks for assessment of the practice of essential newborn care. The data were collected by 5 BSc midwives by using the English version of the questioner and checklist. The data collectors and supervisors were recruited based on their academic status and previous experience in data collection.

To assure the quality of the data, three-day technical training was given for data collectors and supervisors regarding the objectives of the study, methods of data collection, and the significance of the study. A pretest was conducted on 11 obstetric care providers (5%) of the sample size from Dangla woreda. Throughout the data collection, interviewers were supervised. Every afternoon a meeting was held between data collectors, supervisors, and principal investigators to discuss and address any issues arising during data collection. The collected data were checked and reviewed for completeness before data entry.

Data Management and Analysis

The collected data was cleaned code and entered to the Epi-info version 7 and then exported to SPSS version 23. Bivariate analysis was done for all explanatory variables concerning the practice of essential newborn care and variables with p-value < 0.20 in the bivariate analysis were selected for the multivariate logistic regression model for adjustment of confounding effects between explanatory variables. Adjusted odds ratio with 95% confidence interval was computed and variables having P-value less than 0.05 in the multivariate logistic regression model were considered as statistically significant for the practice of essential newborn care. For descriptive statistics like frequency and cross-tabulations, graphical presentations such as tables, bar, and pie charts were used to present the result findings.

Operational Definition

• Essential newborn care: it is sequential care given to all newborn infants starting from delivery of the head and it includes drying and stimulating, evaluation of breathing, cord care, keeping the newborn warm, initiating breastfeeding in the first one hour, administering eye ointment, administering vitamin k intramuscularly, weighing, and putting on an identification band and recording. 20
• Proper practice of essential newborn care: If the obstetrical health care providers perform above the mean score on practice-related tasks on the checklist. 20
• Not practiced properly: not practiced properly: If the obstetrical health care providers perform less than the mean score on practice-related tasks on the checklist. 20
• Obstetrical care provider: health care providers that provide delivery and newborn care service in the delivery ward which could be doctors, nurses, IESO, and midwives. 20

Ethical Consideration

Ethical clearance for this study was obtained from the Institutional review board, College of Medicine and Health Science, of Bahir Dar University. A supporting letter was written by the College of Medicine and Health Science to the Awi zone health office then written permission was given to the selected woreda health bureaus of Awi zone. Health facility managers gave written permission to the MCH (maternal and child health) department head. Before taking the interview the purpose and possible benefit of the study was explained and written permission was obtained from each respondent.

Socio-Demographic Characteristics

The Practice of Essential Newborn Care

Factors That Affect the Practice of Essential Newborn Care

This study revealed that educational level, knowledge of essential newborn care, in-service training, field of study, availability of drugs, and availability of medical equipment were significantly associated with the practice of essential newborn care.

Obstetric care providers who were midwives by profession were about 3.1 times more likely to practice essential newborn care than nurses (AOR = 3.1, 95% CI: 1.35, 7.39). Those obstetrical care providers who received in-service training on essential new born care were 2.7 times more likely to practice essential new born care than those who have not received in-service training (AOR = 2.7, 95% CI: 1.03, 4.49). Obstetric care providers who had good knowledge on essential new born care were 2.1 times more likely to practice essential new born care than obstetric care providers who had poor knowledge on essential new born care (AOR = 2.1, 95% CI: 1.03, 4.49).

Availability of medical equipment for essential newborn care was also significantly associated with the practice of essential newborn care. Obstetrical care providers who can access medical equipments for essential newborns were 2 times (AOR = 2, 95% CI: 1.01, 3.96) more likely to practice essential newborn care compared to obstetric care providers who did not access medical equipment for essential newborn care. Likewise, obstetric care providers who access drugs for essential newborn care were 2.3 times (AOR = 2.3, 95% CI: 1.16, 4.72) more likely to practice essential newborn care as compared to obstetric care providers who did not access the drugs.

The first few hours after birth are the most critical period in the life of an infant for further growth and development, which is mostly determined by the quality of care that the newborn receives.

In this study, the practice of immediate newborn care among obstetrical care providers was 62.7% (95% CI: 55.7, 69.7). The finding of this study is in line with a study done in Bahir Dar town which was 59.7%. 21 This might be due to the similarity of region in which the studies were conducted. This finding was higher than the study done in the central Tigray region which was 52.4%. 22 This difference might be due to the difference in study period in which the study was conducted, 2019 in the case of this study, and 2015 for central Tigray. This study's finding is also higher as compared to a study done in Khartoum which was 41%. 20 This difference might be due to difference in study setting in which the Khartoum study was done only among hospitals, whereas our study also includes health centers. The finding of this study is lower as compared to the study done in the eastern Tigray region which was 72.7%. 15 The difference might be related to the in-service training provided for obstetric care providers on essential care of the newborn which was 45.3% in our study and around 70% in the case of eastern Tigray.

Regarding airway maintenance, in our study 67.7% maintained this by wiping the mouth and nose after delivery of the head. In studies done in the central zone of the Tigray region, and the Ambala district, the practice of airway maintenance was 63.9% and 67.7% respectively. 22 , 23 Additionally, in studies done in El-komminoufiya, Egypt; Khartum; and Bahir Dar, 30.4%, 3.1% and 90%, respectively,of the obstetric care providers maintained the airway of the baby by the wiping of the mouth and nose. 2 , 20 , 21

In this study, 61.7% of obstetric care providers deliver the baby on the maternal abdomen, dry the baby, and only 48.8% of them remove the wet towel. In a study done in Bahir Dar 58.2% of the participants dry the baby and 54.9% of them remove the wet towel. 21 A study done in central Tigray revealed 91.8% of the study participants put the baby on the mother's abdomen and 90.5% of them removed the wet cloth. 22 Another study done in Tanzania on the prevalence of drying the baby on the mother's abdomen and removing the wet cloth was 91% and 93% respectively. 24

In this study, 52.2% of the study's participants had evaluated the breathing while drying and stimulating the baby. In other studies, 92.7% in Khartum and 86.4% in the eastern zone of Tigray region evaluated the breathing of the newborn while drying and stimulating the baby. 15 , 20 In another study done in Egypt it was 47.8%. 2 Avoidance of early cutting of the cord immediately after delivery is very important for the newborn since it promotes placento-fetal transfusion and protects the newborn from developing anemia related to the blood loss that the baby loses when the cord is cut immediately. 25 This study revealed that less than half, 48.8% of the study participants, were aware that cutting the cord of a newborn baby should wait for 2–3 minute after birth or until the cord ceases to pulsate. The finding in other studies done in Ethiopia (32%), Egypt (3%), and Khartoum (8.3%) showed how many participants were cutting the cord only after cessation of the pulsation of the cord. 2 , 20 , 26

Thermal protection is very important and necessary for newborns, which includes skin-to-skin contact. It provides warmth for the new born and it can prevent the complications of hypothermia and it's a significant variable in a study done on hypothermia in Addis Ababa's public hospitals. 27 In this study, only 47.8% of the participants put the baby on skin-to-skin contact after removal of the wet towel. In other studies done in Tanzania, eastern Tigray, central Tigray, and Jimma, 42%, 86.4%, 72.1% and 62.12%, respectively, of the health care providers kept the baby on skin-to-skin contact after removal of the wet towel. 15 , 22 , 24 , 28

Exclusive breast feeding has an important protective effect in opposition to infection. It reduces the risk of hypothermia and hypoglycemia. Additionally, it helps to maintain thermo regulation by keeping the baby close to the mother and this concept is strengthened by a study done in Addis Ababa on hypothermia. 27 This study revealed that 82.1% of the study participants initiate exclusive breast feeding within the first hour of delivery. The findings in other studies done in Jimma, a descriptive study done in Bahir Dar and a study done in Tanzania showed the practice of initiation of exclusive breast feeding within the first hour was 86.4%, 85.8%, and 50%, respectively. 21 , 28 , 29

This study showed that 63.7% of the participants administered eye ointment without the tip of the bottle or the tube touching the eye of the baby or the object, and less than half of the participants, 48.8%, administered vitamin k intramuscularly in the anterolateral part of the thigh with an appropriate dose of vitamin k, which is 1 mg for normal weight, and 0.5 mg for babies with a weight of less than 1500 grams. In studies done in Egypt, 52.6% of the participants put in eye ointment and in a study done in the Jimma zone the percent of administration of eye ointment and vitamin k was 54.8% and 16.9% respectively. 2 , 28 Another study done in the eastern zone of Tigray showed that 73.2% of the participants provided eye ointment, whereas 66.2% of the participants administered vitamin k. 15

About 81.6% of the participants weighed the baby by putting or placing a clean paper on the pan of the weighing scale. A descriptive study done at Bahir Dar town 85.5%, and observational study done in Egypt showed 85.5% and 73.9%, respectively of the obstetric care providers weigh the baby. 2 Regarding the identification band only 5% of the study's participants put the identification band on the newborn in this study. The finding in a study done in Bahir Dar town was 26.8%, and central Tigray region was 0.7%. 21 , 22

The profession of obstetric care providers is one factor for the practice of essential newborn care. Practice of proper essential newborn care was higher among midwives than nurses. This result agreed with a study conducted in the same country in Jimma. 28 The possible reason might be midwives have more chance to work in a labor ward; more chance to receive in-service training on essential newborn care which might, in turn, improves their knowledge and skill over others.

Obstetric care providers who received in-service training on essential newborn care were 2.7 times more likely to practice proper essential newborn care than their counterparts. This result is supported by the studies done in eastern Tigray and Jimma. 15 , 28 This might be due to the fact that in-service training improves the obstetric care provider’s knowledge, and skill to practice essential newborn care.

Obstetric care providers who had a good knowledge were 2 times more likely to practice essential newborn care than obstetric care providers with poor knowledge. This finding is in line with the study done in Jimma. 28 The possible reason might be that knowledge is the core prerequisite to practice essential newborn care.

Obstetric care providers who work in health facilities with adequate medical equipment were 2 times more likely to practice essential newborn care as compared to their counterparts. Moreover, obstetric care providers who work in health facilities with adequate drugs for essential newborn were 2.3 times more likely to practice essential newborn properly compared to obstetric care providers who did not access essential drugs for newborn care.

Regarding educational qualification, the result of this study revealed that degree holders were 0.471 times less likely to practice essential newborn care than diploma holders. This result is supported by studies done in other regions of Ethiopia. 26 But in the studies done in Jimma and Egypt, degree holders were more likely to practice proper essential newborn care, more than diploma holders. 2 , 28 This discrepancy might be due to the fact that in our study participants who were degree holders are nurses and health officers. Additionally, the degree holders might be less experienced than diploma holders which in turn decrease the proper practice of essential newborn care.

A non-participatory method of data collection was held for assessment of practice by using a checklist, there might be Hawthorne bias.

The overall prevalence of essential newborn care practices was low in Ethiopia. In-service training, midwifery profession, availability of medical equipment, knowledge of essential newborn care, availability of drugs, and level of education were found to be predictors of essential newborn care practice among obstetric care providers. Improvements in essential newborn care practices could be attained through modifiable proven interventions like provision of in-service training, availability of drugs, and medical equipment for essential newborn care.

Abbreviations

AOR, adjusted odds ratio; CI, confidence interval; INC, immediate newborn care; ENC, essential newborn care; EDHS, Ethiopian demographic and health survey; OCP, obstetrical care provider; OR, odds ratio; SD, standard deviation; WHO, World Health Organization.

Data Sharing Statement

The data sets generated during the current study are available from the corresponding author ( [email protected] ) on reasonable request.

Ethics Approval and Consent to Participate

Ethical approval and clearance for the study were from the Institutional review board, College of Medicine and Health Science, of Bahir Dar University. A supporting letter was written by the College of Medicine and Health Science to the Awi zone health office, and then written permission was given to the selected woreda health bureaus of Awi zone. Health facility managers gave written permission to MCH (maternal and child health) department heads of the selected health facilities. After explaining the purpose and the possible benefit of the study, written permission was obtained from each respondent before taking the interview. Confidentiality was maintained in each level of the response in this study.

Acknowledgment

The authors would like to pass their gratitude to Bahir Dar University for financial support and approval of ethical clearance to carry out this research. We would like to extend our thanks to Awi zone health bureau and, respectively, the woredas and health offices for providing us with the necessary information and cooperative support for the accomplishment of our research work. Our gratitude also goes to supervisors and data collectors for their hard work in obtaining the necessary information. Our special thanks goes to study participants who generously shared their thoughts and feelings despite other tasks and commitments.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Corresponding Author

Correspondence goes to Asteray Ayenew.

The source of funding to carry out this research was Bahir Dar University. The funding organization has no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript, this was the role of authors.

The authors declare that they have no competing interests for this work.

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6. Kim, Kim YM, Ansari N, et al. Assessing the capacity for newborn resuscitation and factors associated with providers’ knowledge and skills: a cross-sectional study in Afghanistan. BMC Pediatr . 2013;13(1). doi:10.1186/1471-2431-13-140

7. UNICEF W, World Bank Group and UN. Levels and trends in child mortality, 2015 report. Available from: http://www.childmortality.org/files_v20/download/igme%20report%202015_9_3%20lr%20web.pdf . Accessed October 20 , 2020.

8. Central Statistical Agency/CSA/Ethiopia and ICF. Ethiopia Demographic and Health Survey 2016 . Addis Ababa, E., and Rockville, Maryland, USA: CSA and ICF; 2016.

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10. WHO recommendations on ways to improve quality of newborn care in health facilities, a.a.h.w.w.i.f.q.-c.-f.e.

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12. UNICEF/WHO. Skilled Attendance at Birth Joint Database. November ; 2017.

13. Amouzou A, Ziqi M, Carvajal–Aguirre L, et al. Skilled attendant at birth and newborn survival in Sub–Saharan Africa. J Glob Health . 2017;7(2):020504. doi:10.7189/jogh.07.020504

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Effect of home-based newborn care on neonatal and infant mortality: a cluster randomised trial in India

Collaborators.

• A Dadhich ,  A Juneja ,  A Mohanty ,  A Kumar ,  A Srivastava ,  D Ganguly ,  D Sahu ,  H K Dash ,  J K George ,  J Singh ,  K Sen ,  L Kanungo ,  M S Bharambe ,  N Agarwal ,  P V Bahulekar ,  R J Yadav ,  R K Dattatreya ,  R K Gupta ,  R K Sharma ,  R P Singh ,  S K Jha ,  S Kumar ,  S Shakir ,  S Singh ,  T Adhikari ,  U K Singh ,  U Prasad

Affiliations

• 1 Indian Council of Medical Research (ICMR), New Delhi, India [email protected].
• 2 Indian Council of Medical Research (ICMR), New Delhi, India.
• 3 Patna Medical College Hospital (PMCH), Patna, India.
• 4 Mahatma Gandhi Institute of Medical Sciences (MGIMS), Wardha, India.
• 5 National Institute of Applied Human Research & Development (NIAHRD), Cuttack, India.
• 6 Action Research and Training for Health (ARTH), Udaipur, India.
• 7 King George Medical University (KGMU), Lucknow, India.
• 8 National Institute of Medical Statistics, New Delhi, India.
• 9 All India Institute of Medical Sciences (AIIMS), New Delhi, India.
• 10 Sitaram Bhartia Institute of Science and Research (SBISR), New Delhi, India.
• 11 Maulana Azad Medical College (MAMC), New Delhi, India.
• 12 Society for Education, Action and Research in Community Health (SEARCH), Gadchiroli, India.
• PMID: 32972965
• PMCID: PMC7517550
• DOI: 10.1136/bmjgh-2017-000680

Background: Home-based newborn care has been found to reduce neonatal mortality in rural areas. Study evaluated effectiveness of home-based care delivered by specially recruited newborn care workers- Shishu Rakshak (SR) and existing workers- anganwadi workers (AWW) in reducing neonatal and infant mortality rates.

Methods: This three-arm, community-based, cluster randomised trial was conducted in five districts in India. Intervention package consisted of pregnancy surveillance, health education, care at birth, care of normal/low birthweight neonates, identification and treatment of sick neonates and young infants using oral and injectable antibiotics and community mobilisation. The package was similar in both intervention arms-SR and AWW; difference being healthcare provider. The control arm received routine health services from the existing health system. Primary outcomes were neonatal and young infant mortality rates at 'endline' period (2008-2009) assessed by an independent team from January to April 2010 in the study clusters.

Findings: A total of 6623, 6852 and 5898 births occurred in the SR, AWW and control arms, respectively, during the endline period; the proportion of facility births were 69.0%, 64.4% and 70.6% in the three arms. Baseline mortality rates were comparable in three arms. During the endline period, the risk of neonatal mortality was 25% lower in the SR arm (adjusted OR 0.75, 95% CI 0.57 to 0.99); the risks of early neonatal mortality, young infant mortality and infant mortality were also lower by 32%, 27%, and 33%, respectively. The risks of neonatal, early neonatal, young infant, infant mortality in the AWW arm were not different from that of the control arm.

Interpretation: Home-based care is effective in reducing neonatal and infant mortality rates, when delivered by a dedicated worker, even in settings with high rates of facility births.

Trial registration number: The study was registered with Clinical Trial Registry of India (CTRI/2011/12/002181).

Keywords: child health; cluster randomised trial; health services research; public health.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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Conflict of interest statement

Competing interests: None declared

Study timeline. AWW, anganwadi workers;…

Study timeline. AWW, anganwadi workers; SR, Shishu Rakshak; MT, master trainer.

Study profile. NMR, neonatal mortality…

Study profile. NMR, neonatal mortality rate.

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• Volume 8, Issue 11
• Implementing maternal and newborn health quality of care standards in healthcare facilities to improve the adoption of respectful maternity care in Bangladesh, Ghana and Tanzania: a controlled before and after study
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• Alexander Manu 1 ,
• http://orcid.org/0000-0002-7889-2825 Veronica Pingray 2 , 3 ,
• http://orcid.org/0000-0002-8690-6932 Sk Masum Billah 4 , 5 ,
• John Williams 6 ,
• Stella Kilima 7 ,
• Francis Yeji 8 ,
• Fatima Gohar 9 ,
• Priscilla Wobil 10 ,
• Farhana Karim 4 ,
• Projestine Muganyizi 11 ,
• Deus Mogela 12 ,
• Shams El Arifeen 13 ,
• Maya Vandenent 14 ,
• Ziaul Matin 14 ,
• Indeep Janda 15 ,
• Nabila Zaka 16 ,
• Tedbabe D Hailegebriel 17
• 1 Epidemiology and Disease Control , University of Ghana School of Public Health , Accra , Ghana
• 2 Maternal, Newborn and Adolescents Health , UNICEF HQ consultant , New York , New York , USA
• 3 Department of Mother and Child Health Research , Institute for Clinical Effectiveness and Health Policy , Buenos Aires , Argentina
• 4 Maternal and Child Health Division , ICDDRB , Dhaka , Bangladesh
• 5 School of Public Health , The University of Sydney , Sydney , New South Wales , Australia
• 6 Department of Clinical Sciences , Dodowa Health Research Centre, Ghana Health Service , Accra , Ghana
• 7 Research Publication and Documentation Section , National Institute for Medical Research , Dar es Salaam , United Republic of Tanzania
• 8 Planning, Policy, Monitoring, and Evaluation Division (PPMED) , Ghana Health Service, HQ , Accra , Ghana
• 9 Health Section , UNICEF Eastern and Southern Africa Regional Office , Nairobi , Kenya
• 10 Health , UNICEF Ghana , Accra , Ghana
• 11 Department of Obstetrics & Gynaecology , University of Dar es Salaam Mbeya College of Health and Allied Sciences (UDSM MCHAS) , Mbeya , United Republic of Tanzania
• 12 National Blood Transfusion Unit , Ministry of Health, Social Development, Gender, Elderly and Children , Dar es Salaam , United Republic of Tanzania
• 13 MCHD , Icddr B , Dhaka , Bangladesh
• 14 Health , UNICEF Bangladesh , Dhaka , Bangladesh
• 15 Maternal, Newborn and Adolescents Health , UNICEF , New York , New York , USA
• 16 Health , UNICEF Pakistan , Islamabad , Pakistan
• 17 Health , UNICEF , New York , New York , USA
• Correspondence to Veronica Pingray; vpingray{at}iecs.org.ar

Introduction Many women worldwide cannot access respectful maternity care (RMC). We assessed the effect of implementing maternal and newborn health (MNH) quality of care standards on RMC measures.

Methods We used a facility-based controlled before and after design in 43 healthcare facilities in Bangladesh, Ghana and Tanzania. Interviews with women and health workers and observations of labour and childbirth were used for data collection. We estimated difference-in-differences to compare changes in RMC measures over time between groups.

Results 1827 women and 818 health workers were interviewed, and 1512 observations were performed. In Bangladesh, MNH quality of care standards reduced physical abuse (DiD −5.2;−9.0 to –1.4). The standards increased RMC training (DiD 59.0; 33.4 to 84.6) and the availability of policies and procedures for both addressing patient concerns (DiD 46.0; 4.7 to 87.4) and identifying/reporting abuse (DiD 45.9; 19.9 to 71.8). The control facilities showed greater improvements in communicating the delivery plan (DiD −33.8; –62.9 to –4.6). Other measures improved in both groups, except for satisfaction with hygiene. In Ghana, the intervention improved women’s experiences. Providers allowed women to ask questions and express concerns (DiD 37.5; 5.9 to 69.0), considered concerns (DiD 14.9; 4.9 to 24.9), reduced verbal abuse (DiD −8.0; −12.1 to –3.8) and physical abuse (DiD −5.2; −11.4 to –0.9). More women reported they would choose the facility for another delivery (DiD 17.5; 5.5 to 29.4). In Tanzania, women in the intervention facilities reported improvements in privacy (DiD 24.2; 0.2 to 48.3). No other significant differences were observed due to improvements in both groups.

Conclusion Institutionalising care standards and creating an enabling environment for quality MNH care is feasible in low and middle-income countries and may facilitate the adoption of RMC.

• Maternal health
• Intervention study
• Public Health
• Health services research

Data availability statement

Data are available upon reasonable request.

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/ .

https://doi.org/10.1136/bmjgh-2023-012673

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WHAT IS ALREADY KNOWN ON THIS TOPIC

Although respectful maternity care (RMC) is a crucial component of quality of care and a human right, there is evidence that many women do not access RMC, particularly in low-resource settings.

A large body of evidence describes the extent of RMC, and very few studies have evaluated interventions with robust methodologies to address RMC.

WHAT THIS STUDY ADDS

We performed a multicountry comparative before-and-after evaluation to measure the effect of implementing the maternal and newborn health (MNH) quality of care standards on RMC measures.

Implementing MNH quality standards under real-world health system conditions was associated with improvements in effective communication, respectful and dignified care measures and women’s satisfaction. In addition, it improved some contextual factors, enabling environments to support changes and improvements.

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

This study suggests that healthcare facilities and systems in low and middle-income countries can accelerate RMC by implementing MNH quality standards and developing multilevel, context-specific interventions when adequate investment and support are provided.

Introduction

The current global agenda focus on the survival of women and their babies during childbirth and ensuring that they thrive and realise their full potential. 1 Respectful maternity care (RMC) is a human right-based approach that can improve women’s pregnancy, labour and childbirth experience and address health inequalities. 1 RMC refers to care organised for all women and provided to them in a manner that maintains their dignity, privacy and confidentiality; ensures freedom from harm and mistreatment and enables informed choice and continuous support during labour and childbirth. 2 However, many women, particularly those in low and middle-income countries (LMICs), cannot access RMC. 3 Many women experience poor quality of care (QoC) and treatment during childbirth, including disrespect and violations of their rights to privacy, informed consent and having a companion of choice during childbirth. 3–6 These negative experiences of care can prevent women from seeking care in facilities during the postnatal period and for their subsequent deliveries. 4 Additionally, disrespectful, abusive or neglectful care during childbirth may have direct adverse consequences for both the mother and infant. 7

Women place a high value on RMC, and most healthcare providers would like to provide respectful, dignified and woman-centred care but may feel unable to do so due to resource constraints. 8 Most research studies focus on identifying the extent and nature of gaps in providing RMC, and very few evaluate interventions to improve RMC. The latter often focus on training providers and fail to demonstrate a consistent sustained change over time. 9–13 On the other hand, the literature suggests that complex, context-specific interventions targeting multiple levels of the health system are most likely to be effective in improving RMC. 8 9 11 14–18 There is a need to advance from understanding the nature and extent of RMC gaps to developing and evaluating interventions designed to improve and sustain the adoption of RMC. 9

In 2016, UNICEF/WHO published maternal and newborn health (MNH) QoC standards to improve the quality of maternal and newborn care, address health system inequities and strengthen accountability. The nine standards focused on providing evidence-based, safe care; experiencing dignified and respectful care for women and newborns and creating an enabling environment for such care. 19 The standards envisioned experience of care in three domains: (a) effective communication, (b) social and emotional support and (c) respectful and dignified care. Although guidance to improve maternal and newborn care by implementing quality standards has been developed, no study has targeted improving RMC through a standard-based MNH QoC improvement pathway. 20 The implementation of these standards was evaluated in seven intervention districts in Bangladesh, Ghana and Tanzania to inform the feasibility and effect of their institutionalisation within health systems. We present an evaluation of the effect of implementing the MNH QoC standards on RMC measures, focusing on effective communication, emotional support, respectful and dignified care and maternal satisfaction in each country.

Study design

We used a facility-based, controlled before and after design to measure the effect of implementing the MNH QoC standards on RMC measures. The evaluation was conducted in seven intervention districts in Bangladesh, Ghana and Tanzania. Eight adjoining districts with similar characteristics as the intervention districts were evaluated for comparison. Data were collected during two time periods: between October and December 2016 (baseline) and 18 months later, between July and November 2018 (endline) ( figure 1 ). Multiple data collection methods were used: interviews with health workers (HWs), exit interviews with women and observation of woman–provider interaction during and after labour and childbirth. Standards for Quality Improvement Reporting Excellence (SQUIRE) guidelines were used for reporting the results. 21

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Timeline for the evaluation of the effect of implementing MNH quality of care standards implementation in healthcare facilities.

Setting and participants

Participating regions (the Rangpur Region of Bangladesh, the Upper East region of Ghana and the Njombe region of Tanzania) were purposefully selected and prioritised by the ministries of health (MOH) of each respective country. Box 1 describes the context of maternity care in each country. Facilities were selected from the public sector based on their designation to provide emergency obstetric and newborn care, maternity caseload, the absence of quality improvement (QI) interventions at baseline and catchment populations’ sociocultural case mix ( online supplemental table S1 ). A total of 43 health facilities were included: 15 in Bangladesh, 16 in Ghana and 12 in Tanzania. Nineteen intervention facilities were selected to implement the NMH QoC standards. Individual characteristics of each healthcare facility, including the type of model of care, are described in online supplemental table S2 . The intervention was assigned to UNICEF-focused districts based on criteria such as low coverage of health interventions (in Kurigram, Bangladesh), social disadvantages (in Bawku Municipal, Bolgatanga Municipal, Bongo District, Kassena Nankana and West District, Ghana) or poor MNH indicators (Ludewa and Wanging'ombe, Tanzania). Twenty-four control facilities were selected from adjoining districts with populations of similar demographic characteristics. Figure 2 describes participating healthcare facilities, women enrolled, HWs interviewed and woman–provider interaction observations organised by group, time of evaluation (baseline; endline) and country. The population of the intervention districts was approximately 2.8 million. 22–24

Supplemental material

Context of maternity care in bangladesh, ghana and tanzania.

The evaluation was conducted in the Ragpur region, which has a population of 2 069 273.

In 2016, the region had a maternal mortality ratio of 222 deaths per 100 000 live births and 37 neonatal deaths per 1000 live births.

The region has 69 hospitals and 2541 health centres, with 46% of births occurring in health facilities.

Kurigram district was selected to implement the intervention due to low coverage of health interventions, while Gaibandha and Lalmonirhat districts were selected as controls.

The assessment was conducted in the Upper East Region, which has a population of 1 109 338.

In 2016, the maternal and neonatal mortality rates varied depending on the data source. According to the District Health Information Management System, there were 111 maternal deaths per 100 000 live births and seven neonatal deaths per 1000 live births. However, the 2017 Maternal Health Survey reported a mortality risk of 310 maternal deaths per 100 000 live births and 24 neonatal deaths per 1000 live births based on survey data collected in 2014 (Ghana Demographic and Health Survey (GDHS) 2014).

There are 164 healthcare facilities in the region and 1118 Community-Based Health Planning and Services, with 70% of births occurring in health facilities.

Due to social disadvantages, Bawku Municipal, Bolgatanga Municipal, Bongo District, Kassena Nankana and West District were selected to implement the intervention. In contrast, Builsa North District, Kassena Nanakana Municipal, Bawku West District, Talensi District, Gaibandha and Lalmonirhat districts were selected as controls.

The evaluation was conducted in the Njombe region, which has a population of 803 299.

In 2016, the region had a maternal mortality ratio of 101 deaths per 100 000 live births and 31 neonatal deaths per 1000 live births.

The region has 10 hospitals and 263 health centres, with 87% of births occurring in health facilities.

Ludewa and Wanging’ombe districts were selected to implement the intervention due to poor maternal and newborn health indicators, while Njombe and Makete districts were selected as controls.

Participating healthcare facilities, women enrolled, health workers interviewed, and woman-provider interaction observations organised by group and country.

Intervention

The intervention combined several strategies proposed to implement the MNH QoC standards based on QI frameworks that have been shown to change providers’ behaviours, 25 26 institutionalise quality caregiving 27 and address maternal and newborn care quality gaps. 19 28 The main strategies used in the intervention group consisted of implementing the Every Mother Every Newborn QoC standards by (a) establishing and institutionalising QI teams and processes with the involvement of all-level leadership (MOH, district, facility and unit leaders) and (b) creating an enabling environment (including the development of infrastructure) to support the provision of quality care for mothers and newborns. Specific interventions were implemented as part of efforts to improve the care provided and experienced by mothers and caregivers. These included specific training of clinical staff in the intervention facilities on caregiving with compassion and respect as part of training on other QI interventions. Healthcare providers were also trained to engage women and their families in the decisions around the care they experienced, including seeking consent for interventions. Training also covered solicitation of client feedback and using the feedback to improve performance and quality.

In addition, to establish and institutionalise QI processes, QI teams defined change ideas, set objectives around these and implement them within Plan‒Do‒Study‒Act cycles. They use data for decision-making on quality and monitoring improvements.

Creating an enabling environment involved instituting structural changes to ensure better privacy, although temporary. In the case of the latter, some facilities procured curtains to provide separate enclosures for women in labour as part of ensuring visual privacy. Water, sanitation and hygiene as well as overall infection prevention and control measures, were identified as quality issues that affect client experience of care and were emphasised. For instance, it was considered that the cleanliness of the dedicated toilet for women within the maternity unit was a critical component of the experience of respectful care. Creating an enabling environment (eg, physical resources, human resources, policies, guidelines) to support quality care for mothers and newborns was also a key.

The intervention was pragmatically implemented in the context of routine intrapartum. Health facilities in the control group continued usual intrapartum care practice without introducing the MNH QoC standards.

Measures and data collection

RMC was measured along the domains included in the WHO framework to assess the experience of care in the context of healthcare services—effective communication, emotional support and respectful and dignified care—from the perspectives of women, HWs and observers. 19 These were supplemented with input measures (eg, physical resources, human resources, policies, guidelines). 29 Independent clinicians and social scientists were trained for data collection at a 7-day workshop facilitated by the study coordination. Data were collected in each facility with piloted standardised structured paper-based forms, translated to local languages and culturally adapted. Data collectors obtained consent and conducted 1827 exit interviews, interviewed 818 health personnel and directly observed 1512 woman–provider interactions. Given the consecutive invitation of all women, sometimes the same woman who participated in the observation participated in the exit interview. However, this was not a criterion for inclusion in the exit interview, and some women participated only in the observation or only in the exit interview.

Below is a summary of the standardised procedures for measurement and data collection, while detailed information has been published elsewhere. 30

Exit interviews

All postpartum women recently discharged from the postnatal ward were invited to participate, regardless of age and perinatal outcome. Interviews were conducted in private rooms. The questionnaires included sections that explored women’s sociodemographic characteristics and their perceived experience of care during and around intrapartum care, including privacy, HWs’ attitudes, communication, responsiveness to women needs, respect for women’s preferences, satisfaction and experiences of disrespect and abuse.

HW interview

HWs providing care during labour and childbirth (specialists, doctors, midwives and staff nurses) were invited to participate in structured interviews to explore contextual factors potentially influencing practice change, such as formal RMC training, policies and procedures for addressing patients’ concerns, rights and identifying and reporting abuse.

Clinical observations

All women consecutively admitted for labour and childbirth during the data collection visits were invited to participate in the woman–provider interaction observation. The observation was initiated at reception and lasted until the immediate postnatal period. Shifts of independent, external observers covered 24 hours a day and 7 days a week. Each observer stayed with the same woman during the whole process. Data collectors used a structured observation checklist to assess communication between HWs and women, privacy, supportive care, labour and delivery ward layout, occupancy and availability of human resources in health.

Data management and statistical analysis

Data were collected in paper forms and entered into password-protected servers in each country. Study investigators conducted data quality assurance through supportive supervision with biweekly field visits to physically verify the completeness, accuracy and consistency of the data.

The analysis focused on reported and observed measures of RMC. It included several measures for each experience of care domain—effective communication, emotional support and respectful and dignified care. In addition, the experience of care measures was assessed by measuring overall satisfaction with care, HWs’ attitudes, overall hygiene, desire to return to the same health facility and recommendation of the facility to relatives/friends. Finally, we measured selected contextual factors that might enable or inhibit practice change.

We described women, HWs’ and observations’ baseline characteristics in each country using proportions to summarise categorical data, mean and SD or median and IQR according to data distribution for continuous data.

We compared temporal changes in RMC measures (measured as proportions with the exception of the measure ‘Number of HWs on duty’, which was measured on a numerical scale and summarised with means and SD) between the two groups using the difference-in-difference (DiD) analytical approach with models that included the main effects of group, time of evaluation and a two-way interaction term, separately for each country, adjusting for the cluster (facility) effect with robust SEs to correct for heteroscedasticity. This analytical method is used in quasiexperimental (nonrandomised) designs, where the two groups do not start at the same level at baseline. The DiD is implemented by computing two differences between groups: the first is the difference in the outcome variable between the two periods for each group. The second difference is the difference between the differences calculated for the two groups. The DiD estimate represents the differential improvements or declines in the outcomes of interest associated with the intervention. Significance was set at p=0.05, and 95% CIs were reported around estimates. Before conducting the analysis, we compared the characteristics of the groups at baseline and endline and did not find any substantial difference in participants’ characteristics ( online supplemental table S4 ). The composition of the intervention and comparison groups was stable over time. In addition, the outcomes did not determine the selection of intervention districts. Intervention facilities were selected because the local government identified them as being located in areas with socioeconomic disadvantages and poor health indicators. Finally, we assumed that the intervention group’s outcomes would slowly improve (have a parallel trend), similar to the control group, given that RMC is on the international and national agendas. Stata V.14 (StataCorp, College Station, Texas) was used for the analyses.

Patient and public involvement

The data collection instruments were pretested in all three countries to assess their acceptability to women and to adapt them culturally based on their suggestions. We interviewed women and family members in all participating facilities to obtain their perspectives on the care they received during labour and delivery. Special efforts were made to ensure confidentiality by storing all paper forms in locked cabinets with face sheets separated from study forms; electronic data were deidentified using participant ID, and no other identifiers were included in the data set. Women and family members are thanked for their contributions in the acknowledgements of this publication.

Characteristics of women, HWs and observations

Women who participated in the exit interviews were very similar in both groups in all three countries except for Bangladesh, where at baseline, more adolescents (32.5% vs 17.8%) and women with lower education levels were in the intervention group than in the control group (24.6% of women completed middle/high school vs 32.5%) ( table 1 ).

• View inline

Baseline characteristics of participating women, health workers and observations by group and country

Interviewed HWs were similar in both groups at baseline, with a few exceptions. In Bangladesh, in the intervention group, HWs were slightly older (45.3% were ≥40 years old vs 36.2% in the control group), and there were fewer nurses compared with other healthcare cadres (47.2% vs 63.8% in the control group). In Tanzania, the intervention group had slightly fewer young HWs (26.8% were <30 years old vs 45.0% in the control group), more midwives (43.9% vs 30%) and fewer physicians (17.1% vs 27.5%). There were no differences between the intervention and control groups in Ghana, but compared with other countries, HWs were younger, more experienced, and the majority were midwives (65.9%).

The observations across all countries had similar baseline characteristics regarding the type of facility, day of the week, time of arrival (day/night) and woman’s age. A baseline difference was identified in Tanzania, where there were slightly more observations performed in hospitals than in health centres in the intervention group compared with the control group (72.3% vs 58.2%).

RMC measures

Table 2 describes the relative frequencies of each RMC measure for each group (intervention and control), time of evaluation (preintervention and postintervention) and country. Table 3 reports DiD estimates for each RMC measure and country.

Frequency of RMC measures by group, time of evaluation and country

Difference-in-difference estimates for each RMC measure by source of information and country

In the intervention group, women reported a statistically significant reduction in physical abuse (DiD −5.2; 95% CI −9.0 to –1.4). In addition, although statistically non-significant, women reported a reduction in verbal abuse (DiD −8.2; 95% CI −16.6 to 0.09). The proportion of women reporting verbal abuse decreased from 8.7% at baseline to 0.9% at endline in the intervention group, while no changes were observed in the control group. Conversely, statistically non-significant improvements were observed in the control group for outcomes that had lower performance at baseline compared with the intervention group. These outcomes were friendly communication (DiD −11.4; 95% CI −48.5 to 26.5) and HW informing the woman of the findings (DiD −9.8; 95% CI −69.9 to 50.1). Other RMC measures showed similar results, as both groups showed enhancements ( table 2 ). Across RMC measures, changes ranged from 8.7% to 22.9% in the intervention group, and 3.5% to 29.8% in the control group. Measures with modest changes typically had very high baseline rates. An exception was the measure ‘satisfaction with general hygiene’, which, despite low satisfaction rates at baseline (10.3% in the intervention group and 8.3% in the control group), had minimal improvements reported (15.3% in the intervention group and 16.6% in the control group).

A statistically significant improvement was shown in observer-reported communication of the delivery plan (DiD −33.8; 95% CI −62.9 to −4.6) in the control group. The proportion of HWs communicating the delivery plan decreased in the intervention group from 86.3% at baseline to 61.8% at endline, while in the control group, the proportion increased from 60.4% to 69.6%. On the other hand, observers reported statistically non-significant improvements in the intervention facilities in these measures: courteous communication between HWs and women (DiD 16.6; 95% CI −49.6 to 82.7), ensuring privacy during labour (DiD 17.7; 95% CI −28.9 to 64.3) and HWs informing findings to women (DiD 10.6; −33.7 to 60.8).

Women in Ghana reported statistically significant improvements associated with the intervention across various measures of RMC. These improvements included HWs enabling women to ask questions and express concerns (DID 37.5; 95% CI 5.9 to 69.0), considering women’s concerns (DiD 14.9; 95% CI 4.9 to 24.9), being responsive when women asked for support (DiD 5.5; 95% CI 0.7 to 10.3), ensuring privacy (DiD 8.0; 95% CI 0.6 to 16.0), treating women with respect (DiD 5.5; 95% CI 1.0 to 9.9) and reducing verbal (DiD −8.0; 95% CI −12.1 to –3.8) and physical abuse (DiD −5.2; 95% CI −11.4 to –0.9). In addition, more women in the intervention group would select the current facility for another delivery (DiD 17.5; 95% CI 5.5 to 29.4) and they were satisfied with the attitude of health personnel (DiD 9.0; 95% CI 0.9 to 18.5). Women in the intervention group also reported enhanced satisfaction with overall hygiene (DiD 22.5; 95% CI −5.7 to 50.6), although this change was not statistically significant.

Two observer-reported measures showed further but still statistically non-significant improvements associated with the interventions: HWs informing women about the delivery plan (DiD 26.5; 95% CI −40.9 to 93.8) and ensuing privacy during initial examination (DiD 9.5; 95% CI −43.3 to 62.4). Other measures did not show differences, as changes were observed in both groups, including observer-reported privacy, which had notably low rates at baseline.

The intervention was associated with statistically significant improvements in women-reported privacy (DiD 24.2; 95% CI 0.2 to 48.3). Women reported other statistically non-significant improvements with the intervention: friendly communication (DiD 20.2; 95% CI −16.3 to 56.6), HW enabling questions and conerns (DiD 14.6; 95% CI −27.1 to 56.4), willingness to return for another delivery (DiD 18.8; 95% CI −21.9 to 59.5) and high satisfaction with care (DiD 17.0; −12.8 to 46.7). Additionally, the proportion of verbal abuse decreased in the intervention group from 7.1% at baseline to 2.3% at endline. In the control group, it decreased from 2.3% to 1.0%. Other measures did not show differences, mainly because rates improved in both groups or were already high at baseline.

No differences between groups were shown in most observer-reported RMC measures due to improvements in both groups or maintenance of high baseline rates. A statistically non-significant improvement was seen in observer-report privacy during the initial examination (DiD 12.4; −16.2 to 41.0) in the intervention group. Conversely, in the control group, positive trends were noted in observer assessments of HW informing women about the delivery plan (DiD -21.0 to −57.5,14.6) and providing support when women were in pain (DiD −18.2; −65.1 to 28.8).

Environmental factors potentially enabling or acting as barriers to RMC

In Bangladesh, similar trends with input measures were observed in both groups. The labour ward layout improved in both groups. Women’s satisfaction with labour ward toilet cleanliness showed minimal change, despite very low baseline rates ( table 4 ). On the other hand, substantial and statistically significant improvements were reported by HWs in RMC training (DiD 59.0; 95% CI 33.4 to 84.6) and the availability of policy/procedures for both addressing patients’ concerns (DiD 46.0; 95% CI 4.7 to 87.4) and identifying/reporting abuse (DiD 45.9; 95% CI 19.9 to 71.8) ( table 4 ).

Environmental factors potentially enabling or acting as barriers to RMC by group, time of evaluation and country

In Ghana, there was a statistically significant increase in the mean number of staff on duty—mostly midwives (DiD 1.39; 95% CI 0.3 to 3.3)—in the intervention group, and a reduction of open-layout labour wards (DiD −56.0; 95% CI −112.5 to 0.4). At the same time, there was an increase in the intervention group in the proportion of observations, in which all labour ward beds were occupied (DiD 32.6; 95% CI 9.9 to 64.3). In addition, HWs were more likely to report improvements in the availability of both policies/procedures for addressing patient concerns (DiD 19.6; 95% CI −7.6 to 46.7) and clear policies on patients’ rights (DiD 19.2; 95% CI −4.5 to 42.8). There was no difference between groups in the availability of procedures for identifying and reporting abuse or training in RMC.

In Tanzania, the results suggest a favourable trend in the cleanliness of labour toilets in intervention facilities (DiD 21.0; 95% CI −18.1 to 60.0) and an increase in the occupancy of labour wards (DiD 22.0; 95% CI −46.4 to 90.4). No changes were observed in labour ward layouts and staff availability. Although statistically non-significant, an improvement was reported in intervention facilities in the availability of a process for identifying and reporting abuse (DiD 22.6; 95% CI −20.0 to 65.1). Conversely, greater improvements were reported in control facilities in the availability of clear policies on patient rights (DiD −13.6; −60.4 to 3.1).

Finally, we measured the impact of introducing the QoC standards on HWs’ self-assessed provision of RMC ( online supplemental table S3 ). Tanzania was the only site where HWs in intervention facilities reported a statistically significant improvement over time on self-assessed provision of RMC (DiD 0.84; 95% CI 0.21,1.47).

Implementing MNH quality standards for 18 months under real-world health system conditions was associated with some improvements in RMC measures. There was a larger trend in reducing physical and verbal abuse, enhancing privacy and increasing women’s satisfaction in the intervention facilities. However, other measures, such as effective communication and emotional support, showed no difference or varied substantially across countries. In most cases, where no differences were detected, both groups either improved or maintained high rates throughout the study. The availability of policies/procedures addressing patient concerns, patient rights and identifying/reporting abuse increased more in intervention facilities than in control facilities. Nevertheless, the results related to cleanliness, the availability of human resources and their training varied substantially across countries. Only in Ghana did the implementation of the MNH standards show consistent improvements over time across most domains and measures. Overall, women more often reported improvements in RMC than external observers.

Most of the body of evidence has focused on measuring RMC adoption gaps and validating RMC measurement methods. 9 Non-comparative studies consistently suggest improvements in RMC with implemented interventions. 15 31–33 However, we identified that RMC measures in intervention and control facilities tend to improve. This may be because the need for RMC is already clearly identified and puts pressure on the entire health system towards improvement or due to contamination, given the nature of the multilevel intervention. 34 35 Either way, uncontrolled pre–post intervention studies fail to identify whether the improvements are associated with the intervention or secular trends. Very few comparative studies measured the effect of interventions to improve RMC and showed divergent results. 11 17 36 Some authors attribute this to the multiple and complex challenges of implementing change in a low-resource setting and variations in measurement. 9 17 The study that obtained similar results to ours is the one that implemented a complex strategy, which was designed in a participatory manner with multiple stakeholders and levels of leadership, specific to the context and supported structural improvements. 11 Contrary to the most commonly used implementation strategy (the training of HWs), complex, multilevel, context-specific implementation strategies addressing a broad spectrum of barriers (including contextual factors) may be more effective in accelerating the adoption of RMC. 16 37

Consistent with the literature, women reported more significant improvements in care experience compared with observers. 38 39 This may suggest that women may have lower expectations of care experiences than observers or may indicate a possible social desirability bias. These findings further highlight the importance of the discussions around which source to use in measuring RMC objectively, considering potential biases and the cost of the different data collection approaches.

Some results are of particular interest. Intervention facilities in Ghana showed improvements of greater magnitude compared with other countries. The literature reports higher adoption of RMC in midwifery-led care services and lower workload. 40 41 Given that the facilities in Ghana had the highest proportion of midwives and young personnel and that facilities in the intervention group significantly increased the available staff, the question arises as to whether the intervention could have better penetration among young midwives or new personnel. There remains a critical gap in women’s satisfaction with hygiene in Bangladesh and Tanzania. Knowing that women reported high satisfaction levels for other dimensions, these proportions may indicate that facility hygiene is a priority for women and was not addressed in some countries. Finally, emotional support did not improve because the adoption was already high at baseline in Tanzania, but other factors could have played a role in Bangladesh.

This study had several key strengths. It was a prospective multicountry comparative study conducted in 43 health facilities in three countries across two world regions. The intervention was implemented at a large scale (multiple districts) with the participation of numerous key stakeholders and substantial local input and leadership. The data collection involved mixed methods integrating the views of women, HWs and independent observers. It was a study conducted in real-life routine practice conditions, including diverse healthcare facilities, facilitating the generalisability or applicability of the findings to many similar settings around the world. 42 It implemented the standards of care as a package using various standardised methods described in globally available guidelines that could facilitate their reproducibility. The inclusion of trained independent external observers was another strength.

Our study had some limitations. While a controlled before and after analysis is more robust than non-comparative studies, it does have limitations in controlling potential confounding. 43 These effects were minimised by estimating DiD, which assumes that baseline rates are different and compares measure changes over time between groups to obtain an appropriate counterfactual for estimating a causal effect. Nevertheless, since the outcomes of interest are not typically collected in routine health information systems and collecting baseline primary data at multiple points in time was not feasible, we were unable to determine differences in pretreatment trends. Nonetheless, our analysis compared facilities and participants with many similar characteristics, for which parallel trends seem plausible. A ceiling effect was observed for some measures, benefiting the group with lower rates. Second, the country-specific number of clusters may not have been enough to detect some clinically significant point estimates as statistically significant. In addition, a few large facilities may have contributed most of the samples and had most of the improvements. Third, some high RMC rates could have been biased by the Hawthorne effect, which may have overestimated frequencies. We mitigated this with 2 weeks of continuous observation, which we considered sufficient time for participants to return to normal behaviours.

This study provides evidence that implementing MNH QoC standards could accelerate the improvement of some RMC measures in LMICs. Participatory designs are likely to encourage engagement, ownership, and capacity share at multiple levels, potentially driving systems strengthening to achieving universal health coverage with quality and respectful care. Using context-specific solutions may contribute to advancing RMC, provided there is adequate investment and support. The results suggest that a scale-up of implementing MNH QoC standards in LMICs and accelerating women’s access to RMC is feasible and must be a desired goal.

Ethics statements

Patient consent for publication.

Not applicable.

Ethics approval

The study protocol received approval from institutional review boards in the respective countries (ICDDRB in Bangladesh-PR-16024-1/6/2016, Ghana Health Service NHRCIRB226-6/4/2016, NIMR Tanzania-NIMR/HQ/R.8a/Vol. IX/2176-11/4/2016). Participants gave informed consent to participate in the study before taking part.

Acknowledgments

This work was conducted under the UNICEF–BMGF MNCH partnership. We appreciate the contributions from the management and staff of our collaborating institutions at the International Centre for Diarrhoeal Disease Research, Bangladesh, Navrongo Research Centre of the Ghana Health Service, National Institute of Medical Research, Tanzania and the UNICEF country offices in the three countries. We acknowledge the valuable contribution of multiple stakeholders, including global/international experts and professionals in maternal and newborn health, ministries of health and partners in Bangladesh, Ghana and Tanzania. Thanks to Dr. Patience Afulani who provided feedback during the publication development process. We also thank the women and health workers who participated in this study.

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Supplementary materials

Supplementary data.

This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

• Data supplement 1

AM and VP are joint first authors.

Handling editor Seema Biswas

Twitter @Lexxxyman, @TedbabeDegefie

Contributors The study was designed by AM, TDH, SMB, SK, JW, FY, NZ and SEA with technical input from PW, MV, FG, DM, PM forming a team that managed and supported the respective countries to implement the evaluation. FK, FY and SK coordinated the evaluation implementation in Bangladesh, Ghana and Tanzania, respectively and assisted in country-specific data analysis. VP and AM drafted the manuscript and obtained inputs from all the co-authors. VP and AM contributed equally to this paper. The revised manuscripts were proofread and approved by all authors. TH was the guarantor and had overall responsibility for the work and access to all the data.

Funding The Bill and Melinda Gates Foundation funded the study through UNICEF headquarters in New York. The findings and conclusions in this report are those of the authors and do not represent the official position of these organisations.

Competing interests None declared.

Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

Provenance and peer review Not commissioned; externally peer reviewed.

Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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Volume 21 Supplement 1

Every Newborn BIRTH multi-country validation study: informing measurement of coverage and quality of maternal and newborn care

• Open access
• Published: 26 March 2021

Immediate newborn care and breastfeeding: EN-BIRTH multi-country validation study

• Tazeen Tahsina 1 ,
• Aniqa Tasnim Hossain 1 ,
• Harriet Ruysen 2 ,
• Ahmed Ehsanur Rahman 1 ,
• Louise T. Day 2 ,
• Kimberly Peven 2 , 3 ,
• Qazi Sadeq-ur Rahman 1 ,
• Jasmin Khan 1 ,
• Josephine Shabani 4 ,
• Ashish KC 5 ,
• Tapas Mazumder 1 ,
• Sojib Bin Zaman 1 ,
• Shafiqul Ameen 1 ,
• Stefanie Kong 2 ,
• Agbessi Amouzou 6 ,
• Ornella Lincetto 7   na1 ,
• Shams El Arifeen 1   na1 ,
• Joy E. Lawn 2 &

EN-BIRTH Study Group

BMC Pregnancy and Childbirth volume  21 , Article number:  237 ( 2021 ) Cite this article

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Metrics details

Immediate newborn care (INC) practices, notably early initiation of breastfeeding (EIBF), are fundamental for newborn health. However, coverage tracking currently relies on household survey data in many settings. “ Every Newborn Birth Indicators Research Tracking in Hospitals” (EN-BIRTH) was an observational study validating selected maternal and newborn health indicators. This paper reports results for EIBF.

The EN-BIRTH study was conducted in five public hospitals in Bangladesh, Nepal, and Tanzania, from July 2017 to July 2018. Clinical observers collected tablet-based, time-stamped data on EIBF and INC practices (skin-to-skin within 1 h of birth, drying, and delayed cord clamping). To assess validity of EIBF measurement, we compared observation as gold standard to register records and women’s exit-interview survey reports. Percent agreement was used to assess agreement between EIBF and INC practices. Kaplan Meier survival curves showed timing. Qualitative interviews were conducted to explore barriers/enablers to register recording.

Coverage of EIBF among 7802 newborns observed for ≥1 h was low (10.9, 95% CI 3.8–21.0). Survey-reported (53.2, 95% CI 39.4–66.8) and register-recorded results (85.9, 95% CI 58.1–99.6) overestimated coverage compared to observed levels across all hospitals. Registers did not capture other INC practices apart from breastfeeding. Agreement of EIBF with other INC practices was high for skin-to-skin (69.5–93.9%) at four sites, but fair/poor for delayed cord-clamping (47.3–73.5%) and drying (7.3–29.0%). EIBF and skin-to-skin were the most delayed and EIBF rarely happened after caesarean section (0.5–3.6%). Qualitative findings suggested that focusing on accuracy, as well as completeness, contributes to higher quality with register reporting.

Conclusions

Our study highlights the importance of tracking EIBF despite measurement challenges and found low coverage levels, particularly after caesarean births. Both survey-reported and register-recorded data over-estimated coverage. EIBF had a strong agreement with skin-to-skin but is not a simple tracer for other INC indicators. Other INC practices are challenging to measure in surveys, not included in registers, and are likely to require special studies or audits. Continued focus on EIBF is crucial to inform efforts to improve provider practices and increase coverage. Investment and innovation are required to improve measurement.

Key findings

Almost half of all deaths in children under the age of five occur in the first month of life (neonatal period), totalling 2.4 million deaths, with 1 million dying on their birthday [ 1 , 2 , 3 , 4 ]. Most can be prevented with high quality maternal and newborn care, including provision of immediate newborn care (INC) practices as prioritised by the World Health Organization (WHO) [ 5 ].

INC practices include skin-to-skin contact during the first hour of life, immediate drying, delayed cord clamping (1–3 min after birth), and early initiation of breastfeeding within 1 h of birth (EIBF) [ 5 ]. EIBF has high-quality evidence regarding impact on improving neonatal and under-five mortality and morbidity [ 6 , 7 , 8 ], and for improved long-term growth and child development outcomes [ 9 , 10 , 11 , 12 , 13 ]. Delayed cord clamping is also supported by high-quality evidence, and while there are no proven mortality gains, health benefits include lower rates of anaemia [ 14 , 15 ]. Outcome measures for skin-to-skin and immediate drying often focus on short-term hypothermia reduction (excluding premature babies) [ 5 ]. However, the benefits from skin-to-skin care include the promotion of breastfeeding initiation and bonding between mother and child with potential for improved cardiovascular system stability, although evidence is largely observational [ 12 , 16 , 17 , 18 ]. As such, WHO issued a “strong” recommendation for early skin-to-skin contact as soon after birth as possible for all clinically stable neonates [ 17 , 19 ].

Population-based surveys, such as the Demographic and Health Survey (DHS) and Multiple Indicator Cluster Surveys (MICS) are the main source of coverage data for INC practices in low- and middle-income countries (LMICs). These are undertaken every 2 to 5 years in about 60 countries. Currently, core questionnaires for both DHS and MICS include questions to capture EIBF and skin-to-skin initiation. Other components of immediate and essential newborn care (such as drying) are in an optional module specific to newborn care [ 20 ] (Additional file  1 ). Of five studies assessing validity of breastfeeding measures using women’s report in survey, three met the criteria for individual validity analyses [ 21 , 22 , 23 ]; overall accuracy of breastfeeding in survey-report was inconsistent (Additional File  2 ) [ 21 , 22 , 23 , 24 , 25 ]. A similar pattern is seen for women’s report of skin-to-skin initiation [ 21 , 25 ] and immediate drying [ 21 , 23 , 24 , 25 ]. Collection of accurate survey data around the time of birth is challenging due to recall biases of women particularly regarding interventions provided around the time of birth when multiple events are happening simultaneously; pain and/or medications may impede recall; and if newborns are separated from their mothers to deliver care or interventions [ 21 , 22 , 23 , 25 , 26 ] (Additional file 2 ).

Institutional birth rates are increasing, with over three-quarters of births worldwide now in facilities [ 27 ], and many countries are starting to include newborn data within their routine systems [ 28 , 29 , 30 ] in line with multiple global initiatives [ 31 , 32 , 33 ]. Hence, routine facility data collected through health management information systems (HMIS) have potential as a source for coverage, yet validation research has focussed on survey-reported data. To our knowledge, no studies have assessed register-recorded coverage of breastfeeding, although some have assessed in-patient records and found low percent agreement between women’s recall and clinical records [ 34 ].

The timing and sequencing of INC practices represents one dimension of quality of care not generally included in large-scale survey tools [ 35 ], but that might have potential within routine HMIS. Skin-to-skin, immediate drying, delayed cord clamping (1–3 min after birth), and EIBF are all time bound interventions recommended soon after birth [ 5 ]. This research offers a unique opportunity to examine time-stamped data and assess to what extent we can accurately capture timing for these selected INC practices, and if these data could be useful to inform improvements in quality of care.

The Every Newborn Action Plan, endorsed by all United Nations member states, includes an ambitious measurement improvement roadmap [ 36 , 37 ] underlining the imperative to validate indicators for maternal and newborn care. Measurement regarding care at birth needs to advance from health service contact alone (e.g., skilled attendance) to also tracking effective coverage, including content and quality of care [ 37 , 38 ]. Accurate and more frequent data are essential to accelerate progress to Sustainable Development Goals, including Universal Health Coverage. However, many countries do not have regular and reliable data regarding INC practices. The EIBF indicator was prioritised within the Every Newborn measurement improvement roadmap [ 36 , 37 ], given evidence of impact and survey data availability in many countries. This indicator was also proposed by WHO as a potential tracer for other INC indicators having plausibility of linkage; for example, EIBF may coincide with skin-to-skin care [ 39 ].

The Every Newborn -Birth Indicators Tracking in Hospitals (EN-BIRTH) study was an observational study of > 23,000 hospital births in three countries (Tanzania, Bangladesh, and Nepal); detailed methods and selected validity results are reported elsewhere [ 40 , 41 ].

This paper is part of a supplement based on the EN-BIRTH multi-country validation study, ‘ Informing Measurement of Coverage and Quality of Maternal and Newborn Care’ . Here we focus on the measurement of EIBF and if EIBF can be used as a tracer for selected INC practices. There are four objectives:

Assess NUMERATOR accuracy/validity for measurement of EIBF in exit-interview survey of women’s report and in routine labour ward registers compared to clinical observation (gold standard). The denominator for EIBF is ‘live births’. This is consistent with current guidelines and measurement platforms, which also use live births [ 31 , 42 , 43 ].

Review early initiation of breastfeeding as a potential TRACER indicator for other INC practices : Compare observer-assessed coverage of EIBF to observer-assessed coverage of other immediate newborn care practices (skin-to-skin, drying, delayed cord clamping).

Assess TIMING as a dimension of quality of care by describing time to initiation of breastfeeding and the time to the selected INC practices using Kaplan Myer analysis shown by mode of birth.

Evaluate BARRIERS AND ENABLERS to routine labour ward register-recording through qualitative data collection regarding register design, and filling.

EN-BIRTH included five comprehensive emergency obstetric and neonatal care (CEmONC) hospitals: Maternal and Child Health Training Institute, Azimpur, and Kushtia General Hospital in Bangladesh (BD); Pokhara Academy Health Sciences in Nepal (NP); and Muhimbili National Hospital and Temeke Regional Hospital in Tanzania (TZ) (Additional file  3 ). Data collection was from July 2017 to July 2018 (Additional file  4 ). Consenting women and newborns admitted to the labour and delivery wards were observed during birth and the immediate postpartum period. Observations were terminated once women and newborns were transferred out of labour and delivery ward. Exit interview surveys were conducted with women in the hospitals immediately after discharge (Additional file 4 ). All EN-BIRTH data collection tools are open source [ 44 ]. In line with current WHO recommendations, we defined EIBF as occurring within the first hour of life (Additional file  5 ) [ 45 , 46 ]. For objectives 1 and 2, we excluded observations which lasted for less than 1 h after birth as inclusion of these observations could have caused an underestimate in EIBF coverage when compared with register-recorded or survey-reported data. Newborns would not have been counted irrespective of who initiated breastfeeding after the observation was terminated, but during their first hour of life.

Gold standard observer-assessed coverage data were collected by trained clinical researchers using a custom-built android tablet-based application across the 24-h day. The software enabled observers to capture the practice whenever it occurred, and each entry was time-stamped (Fig.  1 ) [ 41 ]. Data collectors were trained to touch a specific button for recording the observed practice (skin-to-skin, drying, cord clamping or breastfeeding) once when it was initiated (colour coding the variable green on the application) (Additional file 5 ). Training materials were standardised across sites and supported with a printed manual available at each site [ 41 ]. In order to assess for bias, background characteristics of women observed for less than 1 h were compared with those of included cases.

Immediate newborn care and breastfeeding practices validation design, EN-BIRTH study. EN-BIRTH validation design comparing observation gold standard with register-recorded and women’s report on exit survey

One year of pre-study register data were extracted and compared to register-records during the study period to assess if the presence of external researchers in the hospital affected register recording [ 47 ]. Inter-rater reliability testing was completed for a subset of 5% of observed cases and data extraction [ 40 ]. All quantitative analyses were undertaken using Stata (version 14). Detailed information regarding the research protocol, methods, and overall validation analysis has been published separately [ 48 ].

Results are reported in accordance with STROBE statement checklists for cross-sectional studies (Additional file  6 ). We were granted ethical approval by institutional review boards in all implementing countries in addition to the London School of Hygiene & Tropical (Additional file  7 ).

Labour ward registers

Pre-printed labour ward registers varied in design. During the study, the Bangladesh sites transitioned to a standardised national register (Additional file 3 ). Tanzania and the revised Bangladesh registers used for this analysis had a specific column for EIBF, both register designs used the wording “breastfed within 1 h of birth”. The Tanzania register requires staff to enter “yes” or “no” (Additional file  8 ), whilst the Bangladesh register required a tick for breastfed, and blank for not done. Nepal had no column to register-record breastfeeding. An overview of register design is available in Additional file 8 .

Objective 1: Numerator validation

Results were reported by hospital and mode of birth (vaginal and caesarean births). Random effects pooled estimates were used to calculate breastfeeding coverage across five hospital sites. We calculated percent agreement between observer-assessed coverage and measured coverage (survey or register), and the proportion of ‘don’t know’ responses from surveys, and ‘not recorded/not readable’ results from routine registers. We calculated individual-level validity metrics (sensitivity and specificity) for practices with ≥10 counts in 2 × 2 table columns. 95% confidence intervals (CIs) were calculated, assuming binominal distribution. Pokhara NP did not have a register column for breastfeeding and was therefore excluded from register-recorded analysis.

Objective 2: Review early initiation of breastfeeding as a tracer indicator for other INC practices

Tracer coverage indicators reduce the number of indicators being tracked, but to be useful must accurately represent all other coverage indicators they replace. We aimed to assess if EIBF can be used as a tracer for other INC practices (skin-to-skin, drying, and delayed cord clamping). To this end, we calculated the percent agreement between pairs of observed interventions (EIBF and skin-to-skin, EIBF and drying, EIBF and delayed cord clamping), by summing the number of newborns who received both interventions and the number who received neither intervention, divided by the number of newborns observed.

Objective 3: Assess timing as a dimension of quality of care

Quality of care is characterised across multiple domains of care provision. In this study, we assessed the timing of INC practices using the custom-built EN-BIRTH software and collected time-stamped observational data. Time to event analyses for skin-to-skin, drying, cord care, and breastfeeding initiation were undertaken using the Kaplan Meier method. All live births were included, excluding babies given bag and mask ventilation, or who weighed less than 1500 g. For this objective, results were censored when the observation terminated, or up to a maximum duration of 12 h of observation.

Objective 4: Barriers and enablers to data collection

As part of the wider EN-BIRTH study, focus group discussions and in-depth qualitative interviews were conducted to understand the barriers and enablers to the use of routine registers in recording various aspects of perinatal care and outcomes [ 48 ]. Detailed qualitative methods and overall results are available in an associated paper [ 48 ]. In summary, we purposively sampled two groups of respondents: hospital health workers providing perinatal care in EN-BIRTH sites (nurses/midwives/doctors) and data collectors involved in the EN-BIRTH study (clinical observers/data extractors/supervisors) for participation in focus group discussions (FGD) and in depth interviews (IDI) (Additional file  9 ). Semi-structured IDI guides and semi-structured focus group guides were developed based on the Performance of Routine Information System Management (PRISM) conceptual framework [ 49 ]. Audio recordings of each interview were transcribed, translated, and managed with pre-identified codebook nodes into NVivo (version 12). Codes included constructs for technical, organisational, and behavioural factors. We also asked the participants to complete a checklist to assess which health worker usually provides care for breastfeeding, for documentation, and the order and timing of recording breastfeeding events in the register. These close-ended questions were asked by the researcher to respondents, immediately after their IDI (but not to FGD respondents).

This multi-country analysis included 23,724 consenting women, with 23,471 babies and 23,015 women being observed (Fig.  2 ). Overall, there were 22,522 live births. Observation data for at least 1 h was available for 7802 live newborns (single and multiple births), and there were 7412 newborn register-records, and 6720 exit-survey interviews. Table  1 presents the background characteristics of 7636 women and 7802 newborns observed for ≥1 h. More than two-thirds of births across all five sites were to women under the age of 30 years. Nearly 22% of women had a caesarean, although mode of birth varied widely across facilities. In Azimpur BD, Kushtia BD and Muhimbili TZ caesarean rates were highest at 53.3%, 30.9%, and 47.5%, respectively. Almost three quarters (77.3%) of births were full term (37+ weeks).

Flow diagram for immediate newborn care dataset, EN-BIRTH study ( n  = 23,015). N  = 23,015 observed women. NP = Nepal. Pokhara (NP) had no register column for early initiation of breastfeeding; therefore Nepal is excluded from register-recorded data

Coverage of EIBF was 10.9% (95% CI 3.8–21.0) for births observed ≥1 h (Fig.  3 ). Coverage was highest in Temeke TZ at 26.0% and lowest in Azimpur BD at 1.8%, where the caesarean section rate was 53.2% (Fig. 3 ). For caesarean births overall, the EIBF rate was 2.4% (95% CI 1.2–3.9) compared to 14.4% (95% CI 5.4–26.7) for vaginal births (Additional file  10 ).

Observer-assessed coverage of immediate newborn care practices, EN-BIRTH study. Drying ( n  = 7784); skin-to-skin ( n  = 7773); Cord clamping within 1–3 min ( n  = 7791); breastfeeding initiation within 1 h ( n  = 7802). Timing parameters as recommended by the World Health Organisation, WHO recommendations on newborn health: guidelines approved by the WHO Guidelines Review Committee. 2017, Geneva

Register-recorded coverage was over-estimated in all sites with a column for this data element (Fig.  4 , Additional file 8 ). Survey-reported coverage of “put to breast” was also higher than the observed prevalence. Percentage agreement for register-recorded data was 24.6% (95% CI 8.5–45.7) with high sensitivity 93.2% (95%CI 68.7–100) and low specificity 13% (95%CI 0.0–43.5) (Additional file  11 ). By facility, Kushtia BD (98.2%) and Temeke TZ (97.3%) had the highest sensitivity, while specificity ranged from 2.8% (95%CI 1.6–4.7) in Kushtia BD to 55.4% (95%CI 52.8–58.0) in Muhimbili TZ (Additional file  11 ). Sensitivity was 93.8% (95% CI 70.7–100.0) for vaginal births and 27.6% (95% CI 12.7–47.2) for caesarean births. Specificity of register-recorded coverage was 8.9% (95% CI 0.2–27.5) for vaginal births and 69.4% (95% CI 66.1–72.5) for caesareans (Additional file  11 ).

Coverage rates for early initiation of breastfeeding measured by observation, register and exit-survey, EN-BIRTH study ( n  = 7802). N  = 7802 babies observed ≥1 h of birth. Bangladesh (BD); Nepal (NP); Tanzania (TZ). Pokhara (NP) had no register column for breastfeeding [ 41 ]

Percentage agreement for the survey-report was 53.8% (95% CI 40.2–67.2) with a sensitivity of 76.9% (95% CI 70.7–82.7), and specificity of 50.0% (95% CI 32.3–67.7). Sensitivity was 82.5% (95% CI 76.4–88) for vaginal births and 0.0% (95% CI 0.0–2.6) for caesarean births. The percentage agreement was highest in Temeke TZ (74.8%) and lowest in Kushtia BD (41.9%). Specificity of survey-report was 35.9% (95% CI 25.8–46.7) for vaginal births and 85.3% (95% CI 62.6–98.5) for caesareans (Additional file  10 ). Background characteristics for participants with ≥1 h of observation and those observed for less than 1 h were assessed and showed that a larger proportion of women observed for less than 1 h had a caesarean birth (Additional file  12 ).

Objective 2: Assess agreement between EIBF with other INC practices

We assessed coverage of four INC practices: skin-to-skin contact, drying, delayed cord clamping, and EIBF using observation data (Fig. 3 ). Drying within 5 min after birth was over 90% in all hospitals apart from Pokhara (75.0%). Provision of skin-to-skin contact within 1 h of birth ranged from 13.5% of babies (Azimpur BD) to 70.5% (Temeke TZ). Cord clamping was universal, but timing varied between facilities with less than half of babies receiving delayed cord clamping during the optimum 1–3 min window.

Observed coverage of EIBF was low in all facilities; consequently, it was not possible to assess the breastfeeding relationship with high coverage INC practices. The exception is skin-to-skin contact during the first hour, which demonstrated close percent agreement in four facilities: 93.9% in Pokhara NP, 85.8% in Azimpur BD, 70.3% in Kushtia BD and 69.5% in Muhimbili TZ. Using Kappa cut-offs, delayed cord clamping had a moderate-to-good agreement with EIBF, ranging from 47.3% in Azimpur BD to 73.5% in Pokhara NP. Percent agreement between EIBF and drying was poor and ranged from 7.3% in Azimpur BD to 29.0% in Temeke TZ (Fig.  5 ).

Agreement between observer-assessed immediate newborn care practices, EN-BIRTH study ( n  = 7802). N = 7802 babies observed ≥ 1 h of birth. Bangladesh (BD); Nepal (NP); Tanzania (TZ). Observation data from Azimpur and Pokhara excluded due to poor inter-rater reliability for observation

Objective 3: Assess timing as a marker of quality of care

Kaplan Meier curves were plotted, showing the time from birth to initiation of skin-to-skin, drying, cord clamping, and breastfeeding (Fig.  6 ). Temeke TZ had the maximum probability of EIBF with a median time to initiation very close to 1 h. This was followed by Muhimbili TZ, however the median time was nearly 3 h. For vaginal births, the results were similar to the overall estimations. The probability of EIBF in Kushtia, Pokhara, and Azimpur within 1 h was lower than 0.3. For caesarean births EBFI was well after 1 h in all facilities with a median time of 240 min in Temeke TZ, the best performing facility.

Kaplan-Meier plots of timing for immediate newborn care practices, EN-BIRTH study. a. Breastfeeding initiation (All: 16,511, Vaginal births: 11,564, Caesarean births: 4944). b. Initiation of drying (All; 18,585, Vaginal births: 12,774, Caesarean births: 5808). c. Skin-to-Skin initiation (All: 17218, Vaginal births:12,199, Caesarean births: 5016). d. Cord-clamping (All: 18,586, Vaginal births: 12,775, Caesarean births: 5808).

Bangladesh (BD); Nepal (NP); Tanzania (TZ).

The timing of drying was consistent across all five facilities and all modes of birth, with almost all babies dried within 5 min. Median time for drying was around 1 min in four facilities but slower in Pokhara NP (Fig. 6 ). In Temeke TZ and Muhimbili TZ, the median time was close to 1 min for initiation of skin-to-skin for vaginal births compared to 1 h in Kushtia BD. Babies born in Azimpur BD and Pokhara NP were least likely to get skin-to-skin contact in the first hour of life. The probability of skin-to-skin initiation for caesarean births was less than 0.1 in the first hour (Fig. 6 ). For vaginal births, the median time for cord clamping was between 1 and 3 min in Azimpur BD, Temeke TZ and Muhimbili TZ. Babies born in Pokhara NP were likely to have cord clamped before 1 min, while this was over 3 min in Kushtia BD (Fig. 6 ). For caesarean births, median time for cord clamping was less than 1 min except for in Azimpur BD and Kushtia BD.

Three main categories were identified as influencing data collection and use in the EN-BIRTH study overall qualitative analysis: 1) register design, 2) register filling and 3) register use [ 48 ]. Register design and filling were influenced by the complexity of local data collection systems and time pressures faced by frontline staff. Figure  7 shows a summary of barriers and enablers for recording of breastfeeding practices as identified in the EN-BIRTH study. No respondents cited use of register data regarding breastfeeding.

Barriers and enablers to routine register recording for immediate newborn care practices, EN-BIRTH study. This figure illustrates the overall barriers and enablers to facility-based data collection identified by EN-BIRTH participants. The bold text are the issues specific to immediate newborn care. The transition from red to green is a reminder that most factors identified by participants could serve as either a barrier or enabling factor depending on the facility-level resources and management

Register design

Both health workers and EN-BIRTH study clinical observers reported factors related to register design, notably the complexity of the documentation system, as a major barrier to recording in registers. One site had no column at all for EIBF, while staff in other hospitals reported duplicitous data demands with the same data elements being recorded in multiple documents:

“There are many registers, it takes time to do all the documentation.” -Health worker, Muhimbili TZ

In Muhimbili TZ, EIBF was documented in a national labour ward register before being tallied by hand and input into the HMIS. Breastfeeding initiation was also supposed to be recorded on the woman’s file, case notes, treatment sheet, and in the “informal midwifery book”.

Register filling

Respondents stated barriers to register filling included valuing completeness over accuracy. Data collectors in Tanzania reported that EIBF may be recorded in the register before newborns had even started breastfeeding:

“ … the nurse usually writes that the baby has been breastfed, even if by that time the baby might not have been breastfed.” -Data collector, Temeke TZ

These findings were consistent with evidence from Bangladesh data collectors, and are reflected in the low observed breastfeeding coverage compared with high register-recorded practice in both sites. Multiple locations for documentation contributed to the complexity of the record-keeping system and these challenges were compounded when breastfeeding was initiated after discharge from the labour wards:

“We don’t fill information about first time breast-feeding because they start it in other places [wards].” -Health worker, Muhimbili TZ

Respondents in all five sites also reported that breastfeeding was not routinely initiated or recorded in the operation theatres, this was especially the case for Bangladesh:

“Breastfeeding is not done in the operation theatre. They never do it in operation theatres.” -Data collector, Kushtia BD

“They usually do not initiate it in the in the theatre, it is initiated in the post-caesarean ward.” -Data collector, Temeke TZ

Across all sites, the primary midwifery or nursing carer was responsible for documentation for women having vaginal births, except Pokhara NP where labour ward registers do not include a column for breastfeeding initiation (Additional file  13 ). Respondents did not know who would record breastfeeding if it was actually done after caesarean section in the operating theatre (Additional files  13 and 14 ).

Data collectors and health workers reported that breastfeeding in Bangladesh is usually assisted by nurses or women’s attendants and is documented in the neonatal register, case notes, discharge letter, and monthly summary sheet. In Nepal, nurse-midwives advise women to initiate breastfeeding within 1 h, but there is no register-recorded documentation.

“We advise the patient, we say, to feed milk within one hour. We have written in the chart to encourage breastfeeding, but it’s not there in registers.” -Health worker, Pokhara NP

Health workers in all three settings reported being busy, and that data recording could be time consuming:

“ … documentation requires time. In the ward we have 35-40 patients, we need to discharge, fill registers, make birth certificates so time is required.” -Health worker, Pokhara NP

There was a potential conflict between administrative responsibilities, such as recording and reporting of data, and provision of clinical care:

“ You have to … respond to her with whatever she wants and [you] forget to document ” -Health worker, Muhimbili TZ

Breastfeeding indicators are rightfully part of the WHO core 100 global indicators for child health and nutrition, given breastfeeding has strong evidence of high impact for reducing mortality and morbidity [ 5 , 6 , 7 , 8 , 16 , 18 , 50 , 51 ]. It has been measured in large-scale, population-based household surveys for decades (Additional file 1 ). Importantly, breastfeeding is also considered to be a marker of respectful maternity care and baby friendly services promoting zero separation of women and their newborns. EN-BIRTH’s large sample size and time-stamped data allowed us to assess validity of measures in both surveys and registers, examine the relationship of EIBF with other immediate newborn care practices, and also to consider differences between vaginal and caesarean births. Coverage of initiation of breastfeeding within 1 h was shockingly low (10.9, 95% CI 3.8–21.0 overall) and very few babies born by caesarean were breastfed, even within several hours. Our results show that EIBF was over-estimated in both register-recorded and survey-reported data compared to the gold standard of observation.

EIBF was harder to measure than most of the other indicators assessed for EN-BIRTH and has also been found to have low accuracy in other survey validation studies [ 51 ] (Additional file 2 ). Over-estimation of EIBF in both survey and registry data could be due to three possible reasons. Firstly, inaccuracies in reporting timing, whereby the newborn was breastfed, but after 1 h. There are well recognized issues for accurate report of timing, and evidence suggests these issues are exacerbated around the time of birth and the immediate postnatal period when both women and health workers may misjudge time [ 22 , 25 ]. In addition, recent evidence from eight countries in Asia and the Pacific suggests a strong dose relationship between skin-to-skin and initiation of breastfeeding within 90 min following birth [ 18 ]. These findings suggest that the window of breastfeeding initiation may be wider than 1 h, and highlight the importance of ensuring health workers have adequate training and support in the implementation of early breastfeeding counselling.

Secondly, breastfeeding is a multistep process and it is possible that data collectors, health workers, or women may identify different parts of the breastfeeding process as the time of EIBF; such as baby put to breast, baby latched, or baby sucking. We note that breastfeeding initiation is not a one-time, easily recorded event like cord cutting or uterotonic injection. EN-BIRTH data collectors received standardised training on observing “initiation of breastfeeding” (Fig. 1 , Additional file 4 ), but may still have applied their own interpretation to the exact time of initiation. In the current DHS and MICS survey question structure, women are asked, “Did you ever breastfeed your baby?” and then, “How long after birth was the baby was put to breast?” which is equally open to interpretation, and counting different points in the process of initiation [ 52 ]. Formative research could help better understand how these processes are interpreted. For example, if register design can improve accuracy by including one part of the process of EIBF, such as “put to breast” or sucking.

Thirdly, breastfeeding may be misreported by health workers or by women, possibly deliberately affected by social desirability for approval [ 22 , 25 ]. Qualitative results suggested that the documentation culture in Bangladesh and Tanzania valued register completeness over accuracy, which exposes the need for training and supportive supervision to improve the accuracy of information included in registers. Health workers were divided across many tasks and did not always prioritise supporting women in initiating breastfeeding, nor accurate documentation. These testimonies also highlight the heavy workload on health providers, with consequences for how staff prioritise and complete their tasks, and might increase pressure for staff to record what they believe is the desirable answer [ 53 ]. Local monitoring and supervision to track different quality of care dimensions for breastfeeding are needed in the study settings, alongside practical facility-level solutions such as designing the ward layout to ensure record keeping can be completed in a convenient location near service users and the clinical area, and implementation of local protocols and training programs. However, changing EIBF and documentation practices is likely to also require health system actions that encompass improvements to human resources, infrastructure, supply and mechanisms for accountability [ 54 , 55 ].

Drying of the newborn and skin-to-skin contact were challenging to measure in survey report for the EN-BIRTH study [ 56 ], and this is consistent with other research [ 22 , 24 , 25 , 34 ]. Indeed, accuracy is expected to worsen over the two to five-year timespan used for DHS and MICS, compared to the exit survey timing in EN-BIRTH. Skin-to-skin is currently included in the DHS core questionnaire, drying in the DHS optional newborn module, and delayed cord clamping is not included in DHS or MICS (Additional file 1 ). For drying, survey-reported percent agreement was > 80% in 4/5 hospitals, but for skin-to-skin initiation was < 50% in three hospitals [ 56 ]. Results regarding individual level validation for survey-report of these INC indicators are detailed in a companion paper [ 56 ]. Cord cutting and drying or clamping are universally practiced for most births; quality of care improvement requires data on timing, and hygienic practices which are better assessed via audit, and other facility-level clinical quality improvement approaches. As such, we do not recommend inclusion of questions in surveys regarding cord clamping, drying, or immediate skin-to-skin for all babies (which differs from kangaroo mother care) [ 57 ].

Our observation data suggests EIBF was a good tracer indicator for skin-to-skin initiation within 1 h of birth in four of five assessed facilities (Azimpur BD, Kushtia BD, Pokhara NP, and Muhimbili TZ). There is compelling plausibility for the agreement between skin-to-skin and breastfeeding [ 18 ]. We also found good agreement between EIBF and delayed cord clamping in three facilities (Kushtia BD, Pokhara NP, and Muhimbili TZ). Coverage of delayed cord clamping and immediate drying was very high while coverage of EIBF was very low; EIBF in this study was not related to immediate drying, although we note that drying was practiced rapidly for virtually all newborns and EIBF was very low. This echoes prior secondary analysis of DHS data, which reported EIBF to be poorly correlated to other INC practices, although we note that the correlated data were based on survey-report with low accuracy, and thus had inherent limitations [ 58 ].

Our time-to-event analysis using the Kaplan Meier curves highlights the rapid timing of skin-to-skin initiation drying, and cord clamping, but major delays in breastfeeding, especially for babies born via caesarean. Given the increasing rate of caesareans, this represents an urgent research gap [ 59 ]. One EN-BIRTH hospital had an observed caesarean rate > 70%, which is high – double the recommended acceptable range of 10–15% [ 59 ]. Given the importance of INC practices, and especially the relationship between EIBF and skin-to-skin [ 18 ], urgent work is required to better understand and address the barriers and enablers for newborn care after caesarean birth, in addition to reducing non-medically indicated caesarean sections.

In these CEmONC hospitals, low rates of breastfeeding indicate gaps in quality of care. Given the well-evidenced, extensive benefits of EIBF, low coverage and delays are startling and may reflect separation of mother and baby. Breastfeeding initiation is crucial for establishing breastfeeding and for multiple other benefits for mother and baby [ 5 ]; hence other essential newborn care interventions such as vitamin K, eye care, immunisations, and assessment of birthweight, gestational age, or congenital conditions should not be prioritised above uninterrupted skin-to-skin and EIBF where possible. More work to assess sequencing and prioritisation of practices is required.

Register design also plays a role, the Pokhara NP register did not have a column to capture EIBF. In three out of four EN-BIRTH sites with a specific column, register-recorded coverage was above 90%. In Tanzania, Temeke and Muhimbili had different register-recorded coverage (95.3% and 43.8% respectively) despite sharing the same register design and having similar observer-assessed EIBF rates (26% and 19.1% respectively). Hospitals in Bangladesh introduced revised registers during the study period, and register-recorded breastfeeding coverage in Azimpur increased from 0 to > 90%, and in Kushtia from 57.3 to 96.8%, despite a maximum observer-assessed EIBF coverage of 9.8% [ 40 ]. These findings suggest that a focus on data accuracy is important, rather than register completeness alone. Further research regarding register filling and context to understand better these variations in performance, which may be rooted in facility-specific differences such as governance and leadership, could help. Facilitating ownership and use of data could also support improved data quality [ 60 ], especially in the operating theatres where health workers reported being unclear on who was responsible for recording in registers, or what data were used for reporting in HMIS (Additional files  13 and 14 ). Introducing data quality assurance systems, training on indicator definitions, and receiving feedback on data could help improve recording practices [ 61 ].

Strengths and limitations

Strengths of this study include the large sample size, and rigorous multi-country design with gold standard with direct observation by clinically trained observers. Observer data could be subject to errors, but this risk was minimised through a custom-built electronic data capture system, standardised training and refresher sessions, and quality assurance through double observation and data entry [ 41 ].

However, there were also limitations. Observation was discontinued when women were transferred out of labour and delivery wards, so we were unable to record EIBF beyond the immediate postpartum period. As the current definition of EIBF includes a 1 h time period, the 12,701 women who were not observed for > 1 h needed to be excluded from the validation analysis. This may have introduced bias as women observed for ≥1 h were more likely to have had a vaginal birth (Additional file  10 ). Having observation data across the full sample for a longer period would enable a more detailed analysis regarding timing, especially validation at 2 h post-birth [ 11 ]. Despite low prevalence of data categorised as “not readable”, inter-rater reliability findings suggested poor agreement between register data extractors in Kushtia BD and Muhimbili TZ (Additional file  15 ). This highlights the potential challenges of data extraction and a need for evidence-based register design and implementation processes to ensure data quality as it moves up the HMIS [ 40 ].

Further research is needed to improve reliable and consistent measurement of the EIBF indicator, as well as comparability between survey and routine register data. Research on register design, implementation, and flow into HMIS is key. Root cause analysis tools could be adapted to identify local solutions for improving quality of maternal and newborn care in health facilities, in line with WHO standards [ 62 ].

In this large multi-site study, most INC practices evaluated had suboptimal coverage and challenges in measurement. EIBF had very low coverage (less than one in five), and even lower for women with caesarean births. Given the global epidemic of caesareans, more focus on supporting women and newborns with EIBF is crucial. Unless measurement accuracy is improved, EIBF coverage changes may be missed. Register-recorded and survey-reported coverage both over-estimated observed coverage of EIBF, demonstrating a need for further research to improve instructions and register design/survey questions. Our analysis suggests that agreement between EIBF and skin-to-skin initiation is high. However, immediate drying and delayed cord clamping are even more challenging to measure in surveys and unlikely to be captured in registers, so they will likely require special audits and studies. Renewed focus is needed to promote zero separation of women and their babies, increase coverage of EIBF and INC practices irrespective of mode of birth, and to ensure and measure INC practices including respectful care practices for every woman and their newborn at birth.

Availability of data and materials

The datasets generated during and/or analysed during the current study are available on LSHTM Data Compass repository, https://datacompass.lshtm.ac.uk/955/ .

Abbreviations

Comprehensive emergency obstetric and neonatal care

Children’s Investment Fund Foundation

The Demographic and Health Survey Program.

Early initiation of breastfeeding

Every Newborn -Birth Indicators Research Tracking in Hospitals study

Health Management Information Systems

International Centre for Diarrheal Disease Research, Bangladesh

Ifakara Health Institute

Dar es Salaam

• Immediate newborn care

Low and Middle Income Countries

London School of Hygiene & Tropical Medicine

Multiple Indicator Cluster Survey

Performance of Routine Information System Management

United Nations Children's Fund

World Health Organization

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Acknowledgements

Firstly, and most importantly, we thank the women, their families, the health workers and data collectors. We credit the inspiration of the late Godfrey Mbaruku. We thank Claudia DaSilva, Veronica Ulaya, Mohammad Raisul Islam, Sudip Karki and Rabina Sarki for their administrative support and Sabrina Jabeen, Goutom Banik, Md. Shahidul Alam, Tamatun Islam Tanha and Md. Mohsiur Rahman for support during data collectors training.

We acknowledge and thank Julia Krasevic for her expertise, in addition to the following groups for their guidance and support.

We are also very grateful to fellow researchers who peer-reviewed this paper.

National Advisory Groups :

Bangladesh : Mohammod Shahidullah, Khaleda Islam, Md Jahurul Islam.

Nepal : Naresh P KC, Parashu Ram Shrestha.

Tanzania : Muhammad Bakari Kambi, Georgina Msemo, Asia Hussein, Talhiya Yahya, Claud Kumalija, Eliudi Eliakimu, Mary Azayo, Mary Drake, Honest Kimaro.

EN-BIRTH validation collaborative group :

Bangladesh: Md. Ayub Ali, Bilkish Biswas, Rajib Haider, Md. Abu Hasanuzzaman, Md. Amir Hossain, Ishrat Jahan, Rowshan Hosne Jahan, Jasmin Khan, M A Mannan, Tapas Mazumder, Md. Hafizur Rahman, Md. Ziaul Haque Shaikh, Aysha Siddika, Taslima Akter Sumi, Md. Taqbir Us Samad Talha.

Tanzania: Evelyne Assenga, Claudia Hanson, Edward Kija, Rodrick Kisenge, Karim Manji, Fatuma Manzi, Namala Mkopi, Mwifadhi Mrisho, Andrea Pembe

Nepal: Jagat Jeevan Ghimire, Rejina Gurung, Elisha Joshi, Avinash K Sunny, Naresh P. KC, Nisha Rana, Shree Krishna Shrestha, Dela Singh, Parashu Ram Shrestha, Nishant Thakur.

LSHTM: Hannah Blencowe, Sarah G Moxon.

EN-BIRTH Expert Advisory Group : Agbessi Amouzou, Tariq Azim, Debra Jackson, Theopista John Kabuteni, Matthews Mathai, Jean-Pierre Monet, Allisyn C. Moran, Pavani K. Ram, Barbara Rawlins, Jennifer Requejo, Johan Ivar Sæbø, Florina Serbanescu, Lara Vaz.

Ethics and consent to participate

This study was granted ethical approval by institutional review boards in all operating counties in addition to the London School of Hygiene & Tropical Medicine (Additional file 7 ).

Voluntary informed written consent was obtained from all observed participants, their families for newborns, and respondents for the qualitative interviews. Participants were assured of anonymity and confidentiality. All women were provided with a description of the study procedures in their preferred language at admission, and offered the right to refuse, or withdraw consent at any time during the study. Facility staff were identified before data collection began and no health worker refused to be observed whilst providing care.

EN-BIRTH is study number 4833, registered at https://www.researchregistry.com .

About this supplement

This article has been published as part of BMC Pregnancy and Childbirth Volume 21 Supplement 1, 2021: Every Newborn BIRTH multi-country validation study: informing measurement of coverage and quality of maternal and newborn care. The full contents of the supplement are available online at https://bmcpregnancychildbirth.biomedcentral.com/articles/supplements/volume-21-supplement-1 .

The Children’s Investment Fund Foundation (CIFF) was the main funder of the EN-BIRTH Study and funding was administered via The London School of Hygiene & Tropical Medicine. The Swedish Research Council specifically funded the Nepal site through Lifeline Nepal and Golden Community. We acknowledge the core funders for all the partner institutions. Publication of this manuscript was funded by CIFF. CIFF attended the study design workshop but had no role in data collection, analysis, data interpretation, report writing or decision to submit for publication. The corresponding author had full access to study data and final responsibility for publication submission decision.

Author information

Shams El Arifeen and Joy E. Lawn are joint senior authors.

Authors and Affiliations

Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research Bangladesh, (icddr,b), 68 Shahid Tajuddin Ahmed Sarani, Mohakhali, Dhaka, Bangladesh

Tazeen Tahsina, Aniqa Tasnim Hossain, Ahmed Ehsanur Rahman, Qazi Sadeq-ur Rahman, Jasmin Khan, Tapas Mazumder, Sojib Bin Zaman, Shafiqul Ameen & Shams El Arifeen

Maternal, Adolescent, Reproductive & Child Health (MARCH) Centre, London School of Hygiene & Tropical Medicine, London, UK

Harriet Ruysen, Louise T. Day, Kimberly Peven, Stefanie Kong & Joy E. Lawn

Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King’s College London, London, UK

Kimberly Peven

Department of Health Systems, Impact Evaluation and Policy, Ifakara Health Institute (IHI), Dar Es Salaam, Tanzania

Josephine Shabani

Department of Women’s and Children’s Health, International Maternal and Child Health, Uppsala University, Uppsala, Sweden

Johns Hopkins University, Bloomberg School of Public Health, Baltimore, USA

Agbessi Amouzou

World Health Organization, Geneva, Switzerland

Ornella Lincetto

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• Qazi Sadeq-ur Rahman
• , Ahmed Ehsanur Rahman
• , Tazeen Tahsina
• , Sojib Bin Zaman
• , Shafiqul Ameen
• , Tanvir Hossain
• , Abu Bakkar Siddique
• , Aniqa Tasnim Hossain
• , Tapas Mazumder
• , Jasmin Khan
• , Taqbir Us Samad Talha
• , Rajib Haider
• , Hafizur Rahman
• , Anisuddin Ahmed
• , Shams Arifeen
• , Omkar Basnet
• , Avinash K. Sunny
• , Nishant Thakur
• , Regina Gurung
• , Anjani Kumar Jha
• , Bijay Jha
• , Ram Chandra Bastola
• , Rajendra Paudel
• , Asmita Paudel
• , K. C. Ashish
• , Nahya Salim
• , Donat Shamba
• , Josephine Shabani
• , Kizito Shirima
• , Menna Narcis Tarimo
• , Godfrey Mbaruku
• , Honorati Masanja
• , Louise T. Day
• , Harriet Ruysen
• , Kimberly Peven
• , Vladimir Sergeevich Gordeev
• , Georgia R. Gore-Langton
• , Dorothy Boggs
• , Stefanie Kong
• , Angela Baschieri
• , Simon Cousens
•  & Joy E. Lawn

Contributions

The EN-BIRTH study was conceived by JEL, who acquired the funding and led the overall design with support from HR. Each of the three country research teams input to design of data collection tools and review processes, data collection and quality management with technical coordination from HR, GRGL, and DB. The icddr,b team (notably AER, TT, TH, QSR, SA, and SBZ) led the development of the software application, data dashboards, and database development with VG and the LSHTM team. IHI (notably DS) coordinated work on barriers and enablers for data collection and use, working closely with LTD. QSR was the main lead for data management working closely with OB, KS, and LTD. For this paper, TT, ATH and HR led the analyses and first draft of the manuscript, working closely with AER, LTD, KP, JEL and SEA. All other authors (QSR, JK, JS, AKC, TM, SBZ, SA, SK, AA, OL) revised the manuscript and gave final approval of the version to be published and agree to be accountable for the work. The EN-BIRTH study group authors made contributions to the conception, design, data collection or analysis, or interpretation of data. This paper is published with permission from the Directors of Ifakara Health Institute, Muhimbili University of Health and Allied Sciences, icddr,b and Golden Community. The authors' views are their own, and not necessarily from any of the institutions they represent, including WHO. EN-BIRTH Study Group :

Bangladesh: Qazi Sadeq-ur Rahman, Ahmed Ehsanur Rahman, Tazeen Tahsina, Sojib Bin Zaman, Shafiqul Ameen, Tanvir Hossain, Abu Bakkar Siddique, Aniqa Tasnim Hossain, Tapas Mazumder, Jasmin Khan, Taqbir Us Samad Talha, Rajib Haider, Md. Hafizur Rahman, Anisuddin Ahmed, Shams Arifeen. Nepal: Omkar Basnet, Avinash K Sunny, Nishant Thakur, Rejina Gurung, Anjani Kumar Jha, Bijay Jha, Ram Chandra Bastola, Rajendra Paudel, Asmita Paudel, Ashish KC. Tanzania: Nahya Salim, Donat Shamba, Josephine Shabani, Kizito Shirima, Menna Narcis Tarimo, Godfrey Mbaruku (deceased), Honorati Masanja. LSHTM: Louise T Day, Harriet Ruysen, Kimberly Peven, Vladimir Sergeevich Gordeev, Georgia R Gore-Langton, Dorothy Boggs, Stefanie Kong, Angela Baschieri, Simon Cousens, Joy E Lawn.

Corresponding author

Correspondence to Tazeen Tahsina .

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Supplementary Information

Additional file 1..

Definition of immediate newborn care indicators (EN-BIRTH, DHS & MICS questionnaires).

Additional File 2.

Previous studies regarding validation for measures of immediate newborn care practices.

Additional File 3.

National context and number of births in EN-BIRTH study hospital.

Additional File 4.

Data collection dates by site, EN-BIRTH study.

Additional File 5.

Observation, survey and register indicator definitions, EN-BIRTH study.

Additional File 6.

STROBE Checklist.

Additional File 7.

Ethical approval by institutional review boards, EN-BIRTH Study.

Additional File 8.

Hospital register design and completion approaches by site, EN-BIRTH study ( n  = 6548).

Additional File 9.

Respondents for focus group discussion and in-depth interviews for EN-BIRTH Study.

Additional File 10.

Individual-level validation in exit-survey report of early initiation of breastfeeding, EN-BIRTH study ( n  = 7802).

Additional File 11.

Individual-level validation of register recording for early initiation of breastfeeding, EN-BIRTH study (n = 7802).

Additional File 12.

Characteristics of women observed in labour and delivery wards for < 1 h, EN-BIRTH study ( n  = 12,554).

Additional File 13.

Assessment of routine recording responsibilities for breastfeeding, EN-BIRTH study.

Additional File 14.

Register recording order and prioritisation for breastfeeding, EN-BIRTH study.

Additional File 15.

Inter-observer agreement for early initiation of breastfeeding using Kappa, EN-BIRTH study.

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Heart transplant list doesn’t rank kids by medical need, Stanford Medicine-led study finds

More babies and children survive the wait for a heart transplant than in the past, but improvements are due to better medical care, not changes to wait-list rules, a new study finds.

August 5, 2024 - By Erin Digitale

The current method of listing children for heart transplant does not always rank the sickest kids first, a Stanford-led study has found. Emily Moskal

The method used across the United States to wait-list children for heart transplants does not consistently rank the sickest patients first, according to a new study led by Stanford Medicine experts.

The study published online Aug. 5 in the Journal of the American College of Cardiology .

Adding nuance to the wait-list system by accounting for more health factors could reduce children’s risk of dying while they await donor hearts, according to the study’s authors. A revision to the way donor hearts are assigned is already in process . The study adds evidence for why it is needed, they said.

“Wait-list mortality, which is the chance that a child will die while awaiting transplant, is higher in pediatric heart transplant than for virtually any other organ or age group,” said the study’s senior author, Christopher Almond , MD, professor of pediatrics. Almond cares for children before and after heart transplantation at Stanford Medicine Children’s Health.

“The current system is not doing a good job of capturing medical urgency, which is one of its explicit goals,” said the study’s co-lead author, economist Kurt Sweat, PhD, who conducted the research as a graduate student in economics at Stanford University. Sweat shares lead authorship of the study with Alyssa Power, MD, who was a postdoctoral scholar in pediatric heart failure/transplant at Stanford Medicine when she worked on the study. 

In the last 25 years, the method used to rank infants and children on the waitlist for heart transplants has been revised three times; the most recent changes took effect in 2016. Over these decades, outcomes improved. Patients’ risk of dying on the waitlist fell from 21% to 13%, even while the total number of pediatric heart transplants increased.

But the decline in deaths is due to improvements in medical care rather than the changes in how organs are allocated, the study found.

“The goals of the current allocation system are to improve wait-list mortality and to allocate organs ethically and fairly,” Almond said. “Wait-list mortality has declined, which is a very good thing, but based on our analysis, it doesn’t look like the allocation changes made the difference. Although the intent behind the current system is to prioritize the children based on medical urgency, we saw that the system is not actually sequencing patients according to their risk.”

Three wait-list categories

Infants and children who need heart transplants are added to a waiting list maintained by the United Network for Organ Sharing, the national nonprofit that manages all organ transplants across the country.

Christopher Almond

Pediatric donor hearts are in short supply, especially for infants and smaller children, as few children die in circumstances that allow their organs to be donated. Matching must account for several factors, including geographic locations of the donor and recipient, immune compatibility, and body size. The matching system is intended to prioritize sicker children for transplant and to function equitably.

The current waitlist relies on few factors to determine where a child ranks and uses only three categories of urgency: 1A, the most urgent status, followed by 1B and 2. Factors used to determine a child’s category include what type of heart problem they have (such as congenital heart disease, which is present at birth, or cardiomyopathy, a heart muscle problem that typically develops after birth) and the medications they are receiving.

The team analyzed data from all 12,408 infants and children less than 18 years of age who were listed for heart transplant between January 20, 1999, and June 26, 2023, in the United States. To see if the current wait-list system was functioning as intended, the researchers used statistical methods, borrowed from economics, that are typically used to study markets.

“From the perspective of economics, we think about this fundamentally as an allocation problem,” Sweat said. “We’ve got this scarce resource of donor hearts, and we want to make sure they’re going to candidates who can get the most usage from them. In the case of pediatric heart transplantation, with such high wait-list mortality, what that usually looks like is you want to prioritize patients who are sicker.”

The team compared how transplant candidates were actually ranked on the waitlist with how the candidates would have ranked if the listing order was based on medical urgency.

They also considered whether improvements in wait-list outcomes aligned chronologically with the allocation changes implemented in 2006 and 2016, which were intended to create a more equitable waitlist.

Wait-list categories don’t work as intended

One of the reasons the chance of dying on the waitlist dropped during the years studied is that children on the waitlist were also healthier in recent years: At the time of transplant, they were less likely to be supported with a ventilator, extracorporeal membrane oxygenation (which works like a heart-lung machine) or kidney dialysis, the study found.

However, the medical status of children within each of the three categories on the waitlist varied widely. In fact, the three categories showed significant overlap in the risk of mortality, the study found. In other words, some very sick children were categorized as priority 2 while others who were not as sick had a 1A status, meaning a less-sick child was sometimes offered a donor heart instead of a sicker child.

Also, the three wait-list categories are so broad that less-sick children were sometimes offered a heart before sicker children within the same category because they had been waiting longer, the study said.

We’ve got this scarce resource of donor hearts, and we want to make sure they’re going to candidates who can get the most usage from them. 

Experts agree that a longer wait should not determine transplant priority, “because it can incentivize programs to list people early so you can build some wait time,” Almond said.

Surprisingly, wait-list rule changes in 2006 and 2016 were not linked to rapid improvements in mortality, as you would expect if the rule changes drove the improvements, the team found.

Rather, mortality decreased gradually from 1999 onward, driven by improvements to medical care, including advancements such as ventricular assist devices — mechanical pumps that support a child’s heart during the wait for transplant — and a better recognition of when to list a child for transplant. Over time, the gap in outcomes between patients of different races decreased, they found — a change that was linked to better outcomes overall.

During the study period, physicians also realized that, in infants whose immune systems are still immature, it is safe to transplant organs even when blood types don’t match. Gradual adoption of this practice helped reduce wait-list mortality in the youngest heart recipients, especially among babies with type O blood, who were previously the hardest to match, the study found.

The study’s findings suggest that the wait-list system should be revised to account for a broader range of medical factors than are currently considered — such as kidney function, liver function and whether a patient is malnourished — and should use the combination of factors to assign each child a numeric risk score to replace the current three categories, the authors said.

“The important thing is moving toward a continuous allocation score and refining it so you can account for the technological innovation that’s happening in patient care in the meantime,” Sweat said.

The revision should also account for whether a patient is healthy enough to benefit and recover from a transplant, Almond said. It would give the highest priority to children with the greatest need who have the best chance to recover from major surgery.

“It’s very challenging because if a patient is on full life support and their organs are shutting down, that person is very sick and may not survive the wait-list period. And if you transplanted them, those same risk factors mean they may not have a good outcome with transplant,” Almond said.

In September 2023, UNOS implemented a new lung transplant allocation system based on a continuous score, and the organization is drafting similar systems for other organs. It plan s to have a proposal for how hearts should be allocated ready for review in 2025.

“It is really complicated to figure out how to do this well, but it appears there is still room for improvement,” Almond said.

Researchers from Stanford Medicine’s Departments of Pediatrics and Cardiothoracic Surgery, the Stanford University Department of Economics, and the University of Texas Southwestern School of Medicine contributed to the research.

The research did not receive funding.

About Stanford Medicine

Stanford Medicine is an integrated academic health system comprising the Stanford School of Medicine and adult and pediatric health care delivery systems. Together, they harness the full potential of biomedicine through collaborative research, education and clinical care for patients. For more information, please visit med.stanford.edu .

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Assessing post-abortion care using the WHO quality of care framework for maternal and newborn health: a cross-sectional study in two African hospitals in humanitarian settings.

BACKGROUND: Abortion-related complications remain a main cause of maternal mortality. There is little evidence on the availability and quality of post-abortion care (PAC) in humanitarian settings. We assessed the quality of PAC in two hospitals supported by an international organization in Jigawa State (Nigeria) and Bangui (Central African Republic, CAR).

METHODS: We mapped indicators corresponding to the eleven domains of the WHO Maternal and Newborn Health quality-of-care framework to assess inputs, processes (provision and experience of care), and outcomes of PAC. We measured these indicators in four components of a cross-sectional multi-methods study: 1) an assessment of the hospitals' PAC signal functions, 2) a survey of the knowledge, attitudes, practices, and behavior of 140 Nigerian and 84 CAR clinicians providing PAC, 3) a prospective review of the medical records of 520 and 548 women presenting for abortion complications and, 4) a survey of 360 and 362 of these women who were hospitalized in the Nigerian and CAR hospitals, respectively.

RESULTS: Among the total 27 PAC signal functions assessed, 25 were available in the Nigerian hospital and 26 in the CAR hospital. In both hospitals, less than 2.5% were treated with dilatation and sharp curettage. Over 80% of women received blood transfusion or curative antibiotics when indicated. However, antibiotics were given to about 30% of patients with no documented indication. Among discharged women in CAR, 99% received contraceptive counseling but only 39% did in Nigeria. Over 80% of women in Nigeria reported positive experiences of respect and preservation of dignity. Conversely, in CAR, 37% reported that their privacy was always respected during examination and 62% reported short or very short waiting time before seeing a health provider. In terms of communication, only 15% felt able to ask questions during treatment in both hospitals. The risk of abortion-near-miss happening ≥ 24h after presentation was 0.2% in Nigeria and 1.1% in CAR. Only 65% of women in the Nigerian hospital and 34% in the CAR hospital reported that the staff provided them best care all the time.

CONCLUSION: Our comprehensive assessment identified that these two hospitals in humanitarian settings provided lifesaving PAC. However, hospitals need to strengthen the patient-centered approach engaging patients in their own care and ensuring privacy, short waiting times and quality provider-patient communication. Health professionals would benefit from instituting antibiotic stewardships to prevent antibiotic-resistance.

© 2024. The Author(s).

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Groundbreaking nipocalimab study of pregnant individuals at high risk for early onset severe hemolytic disease of the fetus and newborn published in The New England Journal of Medicine

Nipocalimab delayed or prevented severe fetal anemia and 54 percent of study participants in the Phase 2 UNITY study achieved a live birth at or after 32 weeks without the need for intrauterine transfusion (IUT)

The AZALEA Phase 3 clinical study is currently enrolling patients: Nipocalimab is the only therapy in clinical development for use in pregnancies at risk for severe hemolytic disease of the fetus and newborn (HDFN)

SPRING HOUSE, Pa., (August 7, 2024) – Johnson & Johnson today announced the results from the Phase 2 open-label UNITY study of nipocalimab for the treatment of alloimmunized a pregnant individuals at risk of early onset severe (EOS) HDFN have been published in The New England Journal of Medicine (NEJM). The UNITY study met its primary endpoint with 54 percent of individuals receiving nipocalimab achieving a live birth at or after 32 weeks gestational age (GA) without the need for IUT. 1 Nipocalimab is currently the only therapy reported to be in clinical development for HDFN, a serious and rare condition that occurs when the blood types of a pregnant individual and the developing fetus are incompatible, potentially causing life-threatening anemia in the fetus or infant. 2 These results showed that nipocalimab delayed or prevented severe fetal anemia requiring treatment prenatally and reduced the need for IUTs in pregnancies at high risk for recurrent EOS HDFN. 1

“The Phase 2 data published in the NEJM are encouraging, as the results support the potential of nipocalimab in the treatment of pregnant individuals with a history of severe HDFN, helping to establish a path forward for further development in this disease in a larger scale Phase 3 study,” said Kenneth J. Moise Jr., M.D., Professor, Department of Women’s Health and Co-Director, Comprehensive Fetal Care Center at Dell Medical School of the University of Texas at Austin and lead study investigator b . “For many patients, severe HDFN has a poor prognosis, and the current standard of care carries with it a high treatment burden, such as repeated IUTs and additional in-utero procedures that require access to specialty care and carry a risk to the life of the fetus. If approved, nipocalimab would be the first non-surgical treatment for pregnancies at high risk of HDFN.” 3

The multicenter, open-label, single-arm Phase 2 UNITY study assessed intravenous nipocalimab from 14-35 weeks in pregnancies at high risk for recurrent EOS HDFN. 1 The primary endpoint of the study is live birth at ≥32 weeks GA without IUT. Study results showed the primary endpoint was achieved in 54 percent (7/13) of pregnancies versus the 10 percent historical benchmark (95 percent CI, 25.1-80.8; P<0.001). 1 The NEJM manuscript includes new data that compares the outcomes of qualifying pregnancies c and on-study (UNITY) pregnancies. 1 The comparison revealed that study pregnancies had a higher proportion of live births (92 percent versus 38 percent), fewer participants requiring IUTs (85 percent versus 46 percent), a later median GA at first IUT (27 and 1/7 weeks versus 20 and 4/7 weeks) and a later median GA at delivery (36 4/7 weeks versus 23 and 6/7 weeks). 1 Additionally, among pregnant individuals who joined the study, seven had a fetus that developed hydrops in their most recent qualifying pregnancy, whereas no incidences of hydrops occurred in the study pregnancies. 1

In the UNITY study, the most frequently reported adverse events were consistent with those common in pregnancy and HDFN. 1 Serious side effects were consistent with HDFN or other pregnancy-related conditions including subchorionic hematoma and premature separation of the placenta. 1 Infections and illnesses in infants of mothers exposed to nipocalimab were consistent with those typically observed in the neonatal and infancy period. 1 No maternal or neonatal/infant deaths occurred in the study. 1 One pregnancy resulted in fetal demise related to a complication of an IUT. 1

The UNITY study demonstrated positive efficacy and safety results which supports a favorable benefit risk profile for nipocalimab. 1 Thus, the UNITY study results support further clinical development of nipocalimab for the treatment of severe HDFN. 1   The AZALEA Phase 3 pivotal study is currently enrolling pregnant individuals at risk for severe HDFN who have a history of severe HDFN in a prior pregnancy(ies) to further assess the efficacy and safety of nipocalimab. 4 In addition, Johnson & Johnson is conducting a Phase 3 study of nipocalimab in fetal and neonatal alloimmune thrombocytopenia (FNAIT), which has been considered to be the platelet counterpart of HDFN. 5 FNAIT is an alloimmune disorder of pregnancy that results when the pregnant person’s immune system attacks fetal or newborn platelets, resulting in thrombocytopenia and risk of bleeding, which can be life-threatening. 6

“We are committed to developing non-surgical options that are effective and have a proven safety profile for the treatment of alloantibody-driven maternal-fetal diseases,” said Katie Abouzahr, M.D., Vice President, Autoantibody Diseases and Maternal-Fetal Immunology Disease Area Leader, Johnson & Johnson Innovative Medicine. “The data published in the NEJM underscore the potential of nipocalimab to address the high unmet medical need in severe HDFN , a serious, life-threatening and rare condition in which no other therapies in clinical development exist.”

Editor’s Notes:

a.  Alloimmunized: immune response to foreign antigens upon exposure to genetically different cells or tissues b.  Dr. Kenneth Moise is a paid consultant for Janssen. He has not been compensated for any media work. c.  Most recent qualifying pregnancy: previous HDFN pregnancy that made the participant eligible for the UNITY Phase 2 study

ABOUT THE UNITY STUDY

UNITY ( NCT03842189 ) is a global, multicenter, non-blinded Phase 2 clinical study designed to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of nipocalimab for the treatment of pregnant individuals at high risk for early-onset severe (EOS)-HDFN. 7 The study enrolled RhD (D) or Kell (K) alloimmunized pregnant individuals with singleton pregnancies at high risk for EOS-HDFN due to an obstetric history of severe fetal anemia, fetal hydrops, or a stillbirth at ≤24 weeks GA. 1 The primary endpoint was live birth at or after GA of 32 weeks, without a need for an intrauterine transfusion (IUT) throughout the entire pregnancy. 1 Safety was monitored for 24 weeks post-delivery for the 13 maternal individuals enrolled, and up to 96 weeks post-birth for infants. Participants received once-weekly intravenous infusions. 1 The study met the primary endpoint, with 54 percent of pregnant participants who received nipocalimab achieving a live birth at or after 32 weeks GA, without the need for an IUT throughout their entire pregnancy. 1

Hemolytic disease of the fetus and newborn (HDFN) is a rare disease (and in its severe form, ultra rare) that arises in pregnancies with maternal-fetal incompatibility in certain red blood cell types. 8 Alloantibodies produced by the maternal immune system against fetal red blood cells cross the placenta during pregnancy and attack fetal red blood cells causing fetal anemia or persist after birth in the neonate to cause neonatal hyperbilirubinemia and anemia. 2 The symptoms of HDFN can range from mild jaundice, to neurotoxic hyperbilirubinemia in the newborn, to life-threatening fetal anemia requiring invasive intervention. 9 The potential for in utero onset at an increasingly earlier GA with increasing risk of severe outcomes may occur with each incompatible pregnancy due to pregnancy-related alloimmunization. 10 Currently no non-surgical interventions are approved for pregnancies at high risk for severe HDFN. 3 Pregnancies affected by severe HDFN may necessitate repeated intrauterine transfusions (IUTs), which are invasive, technically complex surgical procedures performed by specialists at specialized medical centers, and these procedures are associated with an increased rate of fetal mortality and premature birth. 11 , 12 , 13 The most difficult to treat cases of HDFN are early onset severe HDFN (EOS-HDFN) that develops at ≤24 weeks gestational age (GA) and results in significant fetal/neonatal morbidity and mortality. According to the American Journal of Obstetrics and Gynecology , in the U.S., it is estimated that up to 80 of every 100,000 pregnancies are affected by HDFN each year. 14

ABOUT NIPOCALIMAB

Nipocalimab is an investigational monoclonal antibody, purposefully designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies, while preserving immune function without causing broad immunosuppression. This includes autoantibodies and alloantibodies that underlie multiple conditions across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal-Fetal diseases mediated by maternal alloantibodies and Prevalent Rheumatology. 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 Blockade of IgG binding to FcRn in the placenta is also believed to prevent transplacental transfer of maternal alloantibodies to the fetus. 24 , 25

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:

• Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021 and fetal neonatal alloimmune thrombocytopenia (FNAIT) in March 2024
• Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy CIDP in October 2021 and FNAIT in December 2023
• Breakthrough Therapy designation for HDFN by the FDA in February 2024
• Orphan medicinal product designation for HDFN by the EMA in October 2019

ABOUT JOHNSON & JOHNSON

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/ or at www.janssen.com/johnson-johnson-innovative-medicine .

Follow us at @JanssenUS and @JNJInnovMed .

Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.

Media contact: Bridget Kimmel Mobile: (215) 688-6033 [email protected]

Investor contact: Raychel Kruper [email protected]

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

Source: Johnson & Johnson

[1] Kenneth J. Moise Jr., et al. Nipocalimab in Early-onset Severe Hemolytic Disease of the Fetus & Newborn. N Engl J Med. 2024; DOI: 10.1056/NEJMoa2314466.

[2] National Library of Medicine. Hemolytic Diseases of the Newborn. StatPearls Publishing. 2023 Jan. Available at: https://www.ncbi.nlm.nih.gov/books/NBK557423/ . Last accessed: August 2024.

[3] DeMoss, P., Asfour, M. and Hersey, K. Anti-K1 (Kell) antibody expressed in maternal breastmilk: A case report of a neonate with multiple intrauterine transfusions and postnatal exposure to Kell antibody in maternal breastmilk’, Case reports in pediatrics. 2017. Doi:10.1155/2017/6927813. Last accessed: August 2024.

[4] Clinicaltrials.gov. A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN). Last accessed: August 2024. https://clinicaltrials.gov/ct2/show/NCT03842189 .

[5] Orphanet. Fetal and Neonatal Alloimmune Thrombocytopenia. https://www.orpha.net/en/disease/detail/853 . Last accessed: August 2024.

[6] NORD. Fetal and Neonatal Alloimmune Thrombocytopenia. Published online July 2022. https://rarediseases.org/rare-diseases/fetal-and-neonatal-alloimmune-thrombocytopenia/ . Last accessed August 2024.

[7] ClinicalTrials.gov Identifier: NCT03842189. Available at: https://clinicaltrials.gov/study/NCT03842189 . Last accessed: August 2024.

[8] Hemolytic disease of the newborn. Medline Plus. Last accessed: August 2024. https://medlineplus.gov/ency/article/001298.htm

[9] Ree IMC, Smits-Wintjens VEHJ, van der Bom JG, et al. Neonatal management and outcome in alloimmune hemolytic disease, Expert Review of Hematology, 10:7, 607-616, doi: 10.1080/17474086.2017.1331124. Last accessed: August 2024.

[10] Lobato G, Soncini CS. Relationship between obstetric history and Rh(D) alloimmunization severity. Arch Gynecol Obstet. 2008 Mar;277(3):245-8. Doi: 10.1007/s00404-007-0446-x. Last accessed: August 2024.

[11] Texas Children’s Hospital. Intrauterine Transfusion. Available at: https://women.texaschildrens.org/program/texas-childrens-fetal-center/procedures-offered/intrauterine-transfusion . Last accessed: August 2024.

[12] de Winter DP, Kaminski A, et al. Hemolytic disease of the fetus and newborn: systematic literature review of the antenatal landscape. BMC Pregnancy and Childbirth. 2023;23(12). Doi: https://doi.org/10.1186/s12884-022-05329-z . Last accessed: August 2024.

[13] Lindenburg IT, van Kamp IL, van Zwet EW, Middeldorp JM, Klumper FJ, Oepkes D. Increased perinatal loss after intrauterine transfusion for alloimmune anaemia before 20 weeks of gestation. BJOG. 2013 Jun;120(7):847-52. doi: 10.1111/1471-0528.12063.

[14] Delaney M, Matthews DC. Hemolytic disease of the fetus and newborn: managing the mother, fetus, and newborn. Hematology Am Soc Hematol Educ Program. (2015) 2015(1):146-151. doi: https://doi.org/10.1182/asheducation-2015.1.146 . Last accessed: August 2024.

[15] ClinicalTrials.gov Identifier: NCT04951622. Available at: https://clinicaltrials.gov/ct2/show/NCT04951622 . Last accessed: August 2024.

[16] ClinicalTrials.gov. NCT03842189. Available at: https://clinicaltrials.gov/ct2/show/NCT03842189 . Last accessed: August 2024.

[17] ClinicalTrials.gov Identifier: NCT05327114. Available at: https://www.clinicaltrials.gov/study/NCT05327114 . Last accessed: August 2024.

[18] ClinicalTrials.gov Identifier: NCT04119050. Available at: https://clinicaltrials.gov/study/NCT04119050 . Last accessed: August 2024.

[19] ClinicalTrials.gov Identifier: NCT05379634. Available at: https://clinicaltrials.gov/study/NCT05379634 . Last accessed: August 2024.

[20] ClinicalTrials.gov Identifier: NCT05912517. Available at: https://www.clinicaltrials.gov/study/NCT05912517 . Last accessed: August 2024

[21] ClinicalTrials.gov Identifier: NCT06028438. Available at: https://clinicaltrials.gov/study/NCT06028438 . Last accessed: August 2024.

[22] ClinicalTrials.gov Identifier: NCT04968912. Available at: https://clinicaltrials.gov/study/NCT04968912 . Last accessed: August 2024.

[23] ClinicalTrials.gov Identifier: NCT04882878. Available at: https://clinicaltrials.gov/study/NCT04882878 . Last accessed: August 2024.

[24] Lobato G, Soncini CS. Relationship between obstetric history and Rh(D) alloimmunization severity. Arch Gynecol Obstet. 2008 Mar;277(3):245-8. DOI: 10.1007/s00404-007-0446-x. Last accessed: June 2024.

[25] Roy S, Nanovskaya T, Patrikeeva S, et al. M281, an anti-FcRn antibody, inhibits IgG transfer in a human ex vivo placental perfusion model. Am J Obstet Gynecol. 2019;220(5):498 e491-498 e499.

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Nursing Perspective of the Humanized Care of the Neonate and Family: A Systematic Review

Sagrario gómez-cantarino.

1 Department of Nursing, Campus Toledo, Physical and Occupational Therapy University of Castilla-La Mancha, 45071 Toledo, Spain; [email protected] (S.G.-C.); [email protected] (B.M.G.)

Inmaculada García-Valdivieso

2 Mostoles University Hospital (HMOS), Madrid Health Service (SERMAS), 28935 Mostoles, Spain

Mercedes Dios-Aguado

3 Yepes Health Center, Castilla-La Mancha Health Service (SESCAM), 45313 Toledo, Spain; se.mccj.macses@dedm

Benito Yáñez-Araque

4 Department of Physical Activity and Sports Sciences, University of Castilla-La Mancha, Campus Toledo, 45071 Toledo, Spain; [email protected]

Brigida Molina Gallego

Eva moncunill-martínez.

5 Toledo Hospital Complex (CHT), Neonatal and Pediatric Oncology Unit, Castilla-La Mancha Health Service (SESCAM), Theoretical Collaborator University of Castilla-La Mancha, Campus Toledo, 45071 Toledo, Spain; se.mccj.macses@llinucnomem

This systematic review aims to determine the extent to which published research articles show the perspective of health professionals in neonatal intensive care units (NICU), as facilitators of family empowerment. Studies conducted between 2013 and 2020 were retrieved from five databases (PubMed, Cochrane, CINHAL, Scopus, and Google Scholar). The search was carried out from January to October 2020. A total of 40 articles were used, of which 13 studies (quantitative and qualitative) were included in this systematic review. Its methodological quality was assessed using the mixed methods assessment tool (MMAT). In these, the opinions and perspectives of professionals on the permanence and participation of parents were valued. In addition, the training, experiences, and educational needs of nursing within the NICU were determined. The crucial role of health professionals in the humanization of care and its effect on the neonate-family binomial was estimated. However, conceptual changes are needed within the neonatal intensive care units. To implement humanization in daily care, family participation should be encouraged in them. For this, it is necessary to modify hospital health policies to allow changes in the infrastructure that facilitate open doors 24 h a day in special services.

1. Introduction

The role of nursing in the care of newborns (NB) in neonatal intensive care units (NICUs) has evolved over time. This environment has a negative impact on the growth of newborns. Therefore, it is of vital importance to attenuate the stimuli, in order to favour adequate neurological development in the newborn. The newborn individualized developmental care and assessment program (NIDCAP method) aims to individualize care, observing and assessing in a comprehensive way the developmental state, and the ability to cope with the stress of the NB before, during, and after each procedure.

Currently, we are reaching a more humanized assistance and integrating the family as a fundamental part in the care of the newborn and, in turn, including them as main caregivers from birth [ 1 , 2 , 3 ]. Previously, the administration of inpatient care involved the separation of the newborn and the family.

Even the scarce presence of parents during the estimated time of visits was perceived by health professionals as a possible risk factor for the health of the sick newborn. A matter that left parents outside the basic and technical care provided in the NICUs to their children [ 4 , 5 ] was that the family was considered as a stressor and not as a receiving and giving part of care [ 6 ]. Currently, the child and his/her family are perceived as an indivisible unit, recipient of care since the sick child belongs to a family with its own rules and norms [ 7 ].

For the multidisciplinary team, and in particular, for the nursing professionals, integrating the family as a fundamental part of care within the NICUs supposes a change of perspective to involve the family as the main carers. Therefore, the role of nursing has gone from being one of the main caregivers of the newborn within the NICUs to being, at present, a collaborative staff and facilitator of the empowerment of parents [ 2 , 8 ]. This involves the development of new knowledge, skills, and abilities for healthcare professionals, which in the past were of little importance.

The family-centered care (FCC) model carried out in various NICUs returns the importance of the neonate-family binomial as an indivisible unit to be cared for [ 6 , 9 , 10 ]. To carry out this new model of care, it is necessary to provide the multidisciplinary team that attends these units with updated knowledge, tools, and training resources to guarantee quality care based on safety and establish a relationship of trust between healthcare personnel and the family.

Among these new skills are techniques to establish efficient communication, which enables adequate health education. This provides parents with the necessary resources to carry out their role as primary caregivers [ 1 , 4 , 7 , 8 ]. This situation requires specialist pediatric care nursing, to ensure quality care in healthcare. In turn, it is necessary to offer strategies for coping with the stress that working in a NICU unit may entail. Multidisciplinary workspaces are also necessary, where health personnel and families contribute their vision and feel respected within it. NICU nurses positively value training in the FCC model since it is a tool that guides them in the behavioral elements to observe and, in this way, assess and plan care related to the observed behavior [ 3 , 11 ].

The transition to FCC in a stressful environment such as NICUs favors and improves the involvement of parents in the care of their child. It improves communication between the family and health personnel, contributes to the reduction of stress and conflicts, and favors the empowerment of the family as a care provider. This question enables technique and humanization to be harmoniously balanced [ 5 , 6 , 7 ].

The aim of this systematic review is to make the nursing perspective visible within the NICUs, in relation to the healthcare provided to the neonate–family binomial, which is a challenge within these special units, both professionally and in terms of infrastructure. It even investigates the basic and specialized training level that nurses, both new and veteran, have for the development of their skills. The nursing aptitude to function adequately is also perceived, in a highly instrumentalized environment, but where humanized care is highly valued, becoming indispensable.

2. Materials and Methods

A systematic review has been carried out following the Prisma guide [ 12 ], carrying out an exhaustive search in five databases (PubMed, Cochrane, CINHAL, Scopus, and Google Scholar) for articles published from 2013 to 2020. The results of the research were synthesised using strategies that avoid bias and random error. These strategies included systematic sorting of all potentially relevant articles and the description of the methodological design. They also included the analysis and the extraction of information from the articles, as well as the presentation and interpretation of the results.

The search was conducted from January to October 2020. This was due to the difficulty of including studies that reflected the experience and training of nurses within NICUs. It was also due to the need to incorporate studies that encompassed the perspective of humanization of care in terms of both nursing and family.

Research, which includes qualitative and quantitative designs, has been used in this type of study. The search terms and threads that were used are reflected below ( Table 1 ).

Search strategy in databases.

2.1. Selection Criteria

Papers retrieved during the searches were checked against the following inclusion criteria: (1) full-text original report published in a peer-reviewed journal; (2) articles that include the nursing perspective on family involvement in NICUs (Level I, II, and III); (3) studies indicating NIDCAP experiences and training needs of nursing; (4) research that includes the FCC model; and (5) articles written in English or Spanish.

2.2. Data Extraction

The search was conducted by four reviewers (S.G.-C., I.G.-V., M.D.-A., and B.Y.-A.). They read the titles and abstracts of all articles retrieved. When there were doubts about the inclusion of an article in the research, it was resolved by the consensus of the entire research team (S.G.-C., I.G.-V., E.M.-M., B.Y.-A., B.M.G., and M.D.-A.). Information about the author, year, country, study design, study purpose, sample characteristics, main variables, methodological quality level, results, and limitations was extracted from all studies. The results of studies that met the selection criteria were screened for retrieval.

2.3. Assessment of Quality and Level of Evidence

The quality of the selected studies was scored using a critical appraisal tool designed for systematic reviews that include qualitative, quantitative, and mixed studies and called the mixed-method appraisal tool (MMAT) [ 13 ]. The MMAT was developed in 2006, revised in 2011, and its latest version was published in 2018, which has been used in this article [ 13 ]. The list contained five items related to sample size, study measurement, design, presentation of results, and quality of research.

The total quality scores of the studies were calculated by adding up the scores of the five elements individually (range: 0–10). They were also used to categorize the level of evidence provided: studies were defined as high quality (HQ) if they had a total score of eight or more; a total score of five to seven was defined as medium quality (MQ); a score below five was defined as low quality (LQ).

Four reviewers (S.G.-C., I.G.-V., M.D.-A., and E.M.-M.) assessed study quality separately. In addition, a meeting was held to resolve possible disagreements between all the reviewers ( Table 2 ).

List of included studies with quality scores.

HQ: high quality; MQ: medium quality; LQ: low quality. A: sample size (2: more than 100 participants; 1: 10 to 99; 0: fewer than 10 participants); B: study measurement (2: suitable; 1: not very suitable; 0: nothing suitable). C: design (2: suitable; 1: not very suitable; 0: nothing suitable). D: presentation of results (2: relevant; 1: not very relevant; 0: not relevant). E: quality of research (2: very good; 1: good; 0: low).

3.1. General Findings

Once the selected articles were evaluated, it was found that of the 13 included studies, six (46.14%) obtained a score of between 8–10 points, which indicates their high quality [ 15 , 17 , 20 , 24 , 25 , 26 ]. Three of them (23.07%) belonged to qualitative studies, and another three (23.07%) belonged to quantitative studies. On the other hand, five (38.46%) articles were classified as medium quality studies [ 14 , 16 , 18 , 21 , 23 ]. Two (15.38%) of these articles belonged to qualitative research, while three (23.08%) belonged to quantitative studies. Only two (15.38%) studies obtained a score indicating low quality after being analyzed [ 19 , 22 ]. One (7.69%) was a descriptive qualitative study and one (7.69%) a quantitative study.

The flow of search results through the systematic review process is displayed in PRISMA. The initial search retrieved 742 articles, which were reduced to 487 by eliminating duplicates. The titles and abstracts of these 487 studies were screened, resulting in the exclusion of 329 additional studies. Of the 158 remaining, 145 were excluded because they were not original studies, did not focus on the nursing perspective and were developed in the pediatric intensive care units (PICU), and were related to hospital management. Thus, 13 studies were included in the systematic review ( Figure 1 ).

The flow of articles through the search process.

Four studies [ 15 , 16 , 21 , 24 ] were conducted in hospitals with high technology ( n = 6), five studies [ 14 , 19 , 22 , 25 , 26 ] were conducted in general hospitals ( n = 14), and four studies [ 17 , 18 , 20 , 23 ] in medium-sized hospitals ( n = 82).

Regarding the types of studies selected, we found that seven (53.84%) are quantitative studies, of which two (15.38%) were descriptive, two (15.38%) were multicenter, one (7.69%) was cross-sectional, one (7.69%) was non-experimental, and one (7.69%) was logistic regression. A total sample of quantitative studies of n = 2042 (92.94%) was obtained. Regarding qualitative research, six (46.16%) studies were selected, since they met the inclusion criteria, with a total number of participants of n = 155 (7.06%). The sample size of the studies ranged from 10 [ 22 ] to 372 nurses [ 18 ]. The samples were collected from seven different countries: one study in Ireland, three in Spain, one in Sweden, one in Turkey, three in Iran, two in Finland, and two in the USA. Table 3 shows the main characteristics of the selected studies with the participating health professionals.

Characteristics of the studies showing: perspective, training, and humanization of nursing.

3.2. Health Professionals’ Perspective on Parental Involvement

Once the gender variable was analyzed, the selected articles provided significant data, yielding a total sample of n = 2362 professionals. Of these, n = 2197 (93.01%) were women, while n = 165 (6.99%) were men. The latter professionals were related to the NICU, both because they were specialists in neonatology and because they were hospital directors [ 18 ]. Therefore, it can be affirmed that the presence within the nursing profession is mostly female because it is traditionally and culturally linked to care. Even within these units, it is valued that the female presence is significantly higher compared to the male presence [ 18 ].

On the other hand, the age variable provides relevant information since in some of the studies carried out in countries such as Ireland [ 14 ], Spain [ 15 , 16 , 17 ], Sweden, [ 18 ], Iran [ 20 ], Finland [ 21 ], and the USA [ 22 ], it was observed that the mean age of health professionals is approximately 30–40 years. This situation plays a prominent role in encouraging parents to be close to their newborn. From the selected studies, it is highlighted that Spain, Finland, and Ireland [ 14 , 15 , 16 , 17 , 21 ] have a younger nursing population, aged 30 years ( n = 259). On the other hand, it is seen that Iran and the USA [ 20 , 22 ] have a mean age of 40 years ( n = 43), while Sweden [ 18 ] has the oldest nursing group with 40–50 years ( n = 372) of a total of n = 674 nurses. Research shows that the youngest professionals [ 16 ], although focusing on the family as a unit of care and even showing respect for their preferences, are more focused on technology, with their attention to the family being in the background. On the other hand, middle-aged staff [ 20 ] promote interpersonal relationships, an issue that increases family capacities in the care process. It is clear that the most organisational level dedicated to management is developed in studies where the sample is larger [ 18 ], as services are coordinated and favourable environments are provided within the unit itself. Even decision-making is coordinated among the multidisciplinary team including the family.

The youngest (38.42%) and middle-aged (6.37%) healthcare professionals who participated in the studies report that cultural differences or language barriers are diluted through nurse–family participation in the NICU. This is due to the fact that the parents observe the progress of the newborn through their participation in the care. Support groups for parents are also promoted, where similar circumstances are addressed both in pathologies and essential care for the upbringing of their children once they are discharged from hospital [ 15 , 18 , 21 ].

In this sense, the information provided by quantitative studies [ 18 , 19 ] is relevant, since they discover that the participation of parents within the NICU is necessary for the development of newborn rearing skills. For such participation to occur, NICU nurses must be up-to-date in care focused on the neonate–family binomial [ 19 ]. To further this finding, a study conducted in Finland shows that well-trained nurses ( n = 22 NICU nurses N-III) facilitate the establishment of a family-centered culture of care [ 21 ]. Thus, from the point of view of these professionals, the participation of parents within the NICU manages to raise the quality of care, allows greater confidence in their professional role, and achieves satisfaction with the work performed [ 20 ].

The qualitative study carried out by Toivonen [ 23 ] in which n = 51 professionals ( n = 32 nurses and n = 19 medical managers) participated, shows that, with the participation of parents in the NICU, they are the ones who manage to perform basic care that facilitates the comfort of the newborn. This fact allows them to perceive the comfort of their newborn and consequently reduce their level of stress, which is inherent in hospitalization [ 20 ]. In this sense, it should be noted that parental participation modifies the nursing role because, through the involvement of parents, an atmosphere of complicity with the nursing staff is generated in the NICU. In this way, the nursing role goes from being an active caregiver to a support facilitator for the newborn’s parents, an issue visible in the study carried out in Finland [ 21 ].

The information provided by a qualitative study conducted in Iran in 2020 is worth dwelling on [ 26 ]. This research affects the need for education and training of nursing staff ( n = 25) to carry out FCC. They even insist on training to carry out care with the mother present, using the kangaroo method. Currently, health personnel ( n = 40 nurses and neonatologists) must provide instruction, training, and even teach parents of different cultures, beliefs, and socio-cultural levels, while carrying out their care work.

However, it is interesting to highlight another qualitative study also conducted in Iran in 2019 [ 25 ], ( n = 120 nurses) that warns that parental involvement is not a new concept in the field of newborn care, although this practice is being implemented ideally in many countries [ 18 , 19 ]. Nevertheless, it is true that the study carried out in Iran [ 25 ] shows that changes in the health policies of the center will be necessary if a hospital does not have adequate resources that allow the development of a culture of care centered on the family. This can translate into increased funding for increased staffing, NICU renovation, ongoing staff training, and even parent accommodation.

3.3. NICU Nursing Training, Needs, and Experience

Of the 13 studies selected, nursing experience or specialization within the NICU is reflected in nine (69.23%) of the studies reviewed, with a total sample of n = 1.346 nurses. Research has revealed that nurses must be trained to educate parents on the most appropriate ways to care for their newborns. Care improves when it is offered by nursing with more years of experience and better training. Thus, the research reviewed indicates that n = 342 nurses have a range of work experience of 0–5 years. While n = 812 nurses have an experience of 5–15 years, and n = 192 nurses are providing their services in the NICU for a period longer than 15 years [ 15 , 16 , 17 , 20 ].

Therefore, the nursing group that has an average of 5–15 years worked (14.26%), guarantees that the time factor is comparable with better training, which results in a higher quality of patient care and interventions in the neonate without forgetting that new nurses and those with less experience within the NICU also have training in FCC [ 15 , 16 ]. This situation highlights the need to update knowledge with an FCC approach, which should be mandatory within special services, involving the entire multidisciplinary team including psychologists [ 17 , 20 ].

In this sense, an investigation carried out in Sweden in 2017 with n = 443 professionals clarified that, for the medical profession, this participation gained importance as the FCC culture was introduced in the NICU [ 18 ]. Therefore, according to this study, physicians ( n = 71) should also undergo FCC training periods in addition to n = 372 nurses. On the other hand, an investigation reveals how the most experienced nursing personnel provide care to the newborn from the first moment of their admission to the NICU, focusing their attention on the neonate–family binomial, while the newer personnel focus their immediate attention on the newborn despite having the necessary training in FCC [ 19 ].

3.4. Humanization of Care in NICU: Promotion of the Nurse-Family Relationship

Among the 13 documents selected to carry out this systematic review, there are outstanding investigations focused on the humanization of care in the NICU. Specifically in the USA, the studies carried out by Coasts [ 22 ] and Gilstrap [ 24 ] refer to the need for n = 24 nurses to establish a positive relationship with parents, which makes it possible to humanize the personnel–family relationship within the NICUs.

Through this mode of relationship, an atmosphere of cordiality is generated between the nursing staff and the parents. Therefore, when delving into this sense, one of the investigations [ 24 ] clarifies that, to establish this relationship with the parents, it is essential to avoid the rotation of the personnel assigned to care for the newborn at least for a period of six months. Thus, of the n = 14 nurses in the study, n = 10 (71.42%) had day shift, n = 2 (14.28%) night shift, and n = 2 (14.28%) performed both shifts. It is appreciated that unnecessary rotations can hinder the beginning of trust between the nursing staff and the family. This being essential to start and maintain a positive nurse–family relationship. Even the change of shifts (morning, afternoon, and night) can deteriorate a previously built relationship between the nursing staff and the family.

In a qualitative study of n = 22 nurses, it is valued that humanized care is enhanced when parents are allowed to spend more time in the NICUs [ 21 ]. This issue favors greater participation in basic care and a close, more effective relationship with the nursing staff. This relationship between nursing and family allows us to express the suffering and concern accumulated by each of the members of the family unit [ 18 , 21 ]. In a study carried out in Sweden [ 18 ] with a sample of n = 443 health professionals, of which n = 372 (83.97%) were nurses, it can even be seen that the greater the experience of the health professionals within these units, the greater the relationship with the family is promoted. On the other hand, the study carried out in Finland [ 21 ] indicates that there is a greater understanding between the more mature nurses and the family, achieving a pleasant and trusting atmosphere within the NICUs. This promotes smooth communication with parents, even when their children are admitted to intensive care [ 21 ]. This situation leads to positive feedback between staff and family [ 18 , 21 ].

One of the research conducted in the USA in 2018 with n = 10 nurses states that the FFC model promotes open and inclusive communication between nursing and the family. The family gradually loses its fear of the newborn’s fragility [ 22 ]. This allows them to receive real-time information about their child’s health status.

This mitigates their hopelessness and manages to humanize care within the unit [ 22 ]. It is also appropriate to clarify that nursing demands to be an active member of health policies that promote the permanence of the family within the NICUs. Through the FCC, parents are encouraged to participate in the care of their newborn. Even one of the qualitative studies carried out in Finland in 2019 with a sample of n = 32 nurses involved the family in carrying out basic tasks of caring for the newborn since, upon discharge from the hospital, the parents will carry out such care at home [ 23 ].

However, not all nursing personnel ( n = 42 nurses) are motivated to carry out their work activity in the presence of the family within the NICU. On occasions, parents do not stop asking questions, which prevents the performance of techniques between the staff and even when it is vital to perform emergency care in a critical situation [ 22 ]. The influence of the environment of these units must be taken into account. Even the stress that can be generated among nurses and family members makes the communication strategies used by these professionals very important, without forgetting that the number of newborns to be cared for, their weeks of gestation, and the number of nurses within the unit and their levels of experience will also have an influence [ 22 , 23 ].

Therefore, in relation to the humanization of care in the NICUs, some of the investigations warn that it is necessary to adapt to private spaces where parents can be alone with their children [ 22 , 23 ]. This means adapting the units with spaces where information can be transferred between professionals, in turn, equipped with technology that allows continuous supervision and monitoring of the newborn as a safety tool. Which facilitates the family privacy necessary to establish the parental role [ 23 ].

It is worth dwelling on the information provided by a study carried out in Ireland in 2013, where the opinion of n = 250 nurses from seven hospitals was collected. They considered that financial support to families is essential to implement the humanization of newborn care. Because of the expenses that newborn care represents for the parents, their travel to the hospital, personal hygiene, and maintenance during the admission of their child can have an economic impact for families that is difficult to assume [ 14 ].

The n = 53 nurses, belonging to four NICUs (with care experience between 10–11 years) who participated in the study carried out in Turkey in 2017, reported that to implement the FCC model, the first point where the institution must intervene is with personnel, who must be trained and motivated to develop their professional practice within these units. The workload that professionals have within the unit in relation to the care of the newborn will not be an obstacle, but it will be a driving factor to change the professional role for the different levels that make up the units. A greater approach is even valued in nurses (with a mean age of 32 years) who have their own family and descendants [ 19 ].

4. Discussion

The objective of this systematic review was to examine the perspective of healthcare personnel in NICUs as facilitators of family empowerment. A total of 13 studies were selected that met the inclusion criteria, which were conducted from 2013 to 2020. They were diverse in their methodologies (quantitative and qualitative). The results obtained were related to the perspective of the professionals in the administration of care, the need for more specialized training within special units such as the NICUs, and the more humanized contact between the professionals and the family.

In relation to the gender variable, the data showed that, at present, the presence of females continues to be much higher than males in the nursing profession. In fact, some studies value that the female nurse figure incorporates concepts such as participation and negotiation to enhance family empowerment [ 4 , 6 ]. Nursing even covers the demands of the family by including them in the care plan and detecting their needs [ 27 ].

The age variable reflected that the largest group is the one with more years of experience in complex units such as the NICU. Specifically, this group of nurses has an age between 40 and 50 years. The results support that these years of care practice play a crucial role in training parents as primary caregivers [ 28 , 29 ]. Curiously, it is found that the newest nurses are those with the most university training, an issue that encourages family participation, although it is true that since they do not have enough work experience, they focus more on offering care technicians to the newborn [ 15 , 16 , 17 , 20 ].

However, in recent decades, a training process has been favoured for university graduates, with a command of the scientific method and with a multi-professional approach, which allows greater understanding, interpretation, and solution of the problems related to their healthcare activity [ 23 ]. For its part, another study [ 28 ] considered that permanent training and systematic updating of professionals within special units leads to the improvement of job performance. This encourages professional improvement to develop through a set of organizational forms that complement and enable the study and dissemination of social, scientific, and technological advances that influence better healthcare [ 23 ].

In recent decades, there has been a movement to strengthen improvement in nursing, recognized through the World Health Organization (WHO), which gives a strategic character to its actions. This scenario allowed the emergence of postgraduate nursing programs in different countries [ 30 ]. In fact, in Spain, one can speak of the specialty in pediatric nursing through the internal resident nurse (EIR) system. In these studies, nurses received specific training related to family involvement in neonatal care [ 20 , 26 ].

Therefore, the process by which nursing decides to specialize closely relates to Benner’s theoretical model, in which the process followed by a healthcare professional is exposed until specialization in a specific area is reached [ 31 ]. This theory even shows how nursing goes through a series of stages until reaching the expert level (beginner, advanced beginner, competent nurse, efficient nurse, and expert nurse) [ 32 ].

In this sense, it is found that the expert nurse resolves critical situations, strives to improve care, and promotes changes in daily routines, achieving patient and family satisfaction [ 31 , 32 , 33 ]. It corresponds to the nurse involved in the formation of the family, as it is an indispensable pillar for the care of the newborn [ 15 , 16 , 17 ]. In this way, parents become protagonists of the care process, promoting much more active experiences [ 26 , 30 , 34 ]. This philosophy considers that the nursing team in the NICUs must have an integrative vision that combines scientific, technological, human, and emotional aspects, in continuous evolution aimed at excellence in care [ 31 , 32 ].

Currently, there are numerous demands in Spain on the part of parents regarding the extension of hours within the NICU. Even in 2013, an agreement was reached between the Ministry of Health and the Autonomous Communities (CCAA) to promote the opening of NICUs 24 h a day, although this situation in Spanish hospitals is not fully met [ 35 ]. Even though it is true that there is controversy among professionals, it is found in the reviewed studies that healthcare professionals see it as adequate to provide support to the family, but their desire not to involve them in care is also perceived [ 18 , 19 , 20 ]. However, other studies affirmed that the professionals consider parental presence beneficial and adequate, both for the neonate–family binomial and even for the nursing staff, reducing their level of stress [ 21 , 22 , 23 ]. Nevertheless, the change that is taking place towards open-door NICUs enables a transformation towards the humanization of care [ 36 ]. To provide adequate care for the newborn and the family during hospitalization, it is necessary that there be a good nurse–patient relationship, and an adequate number of them in work shifts (morning, afternoon, and night). This even enhances the continuity of care by the same professional, avoiding unnecessary shift rotations. These services guarantee the provision of comprehensive and continuous care to the critically ill neonate [ 24 , 37 , 38 ]. Therefore, nursing within the NICU must promote a new paradigm where holistic and global care meets the needs of the newborn and the family, in one of the most critical moments after birth [ 28 , 33 , 39 , 40 ].

Measures that can be applied in NICUs are proposed to enhance the humanization of newborn and family care are as follows:

• (1) Health policies should be promoted that allow hospitals to remain open 24 h, where the family’s presence can be uninterrupted. This issue promotes their inclusion within the healthcare team.
• (2) Healthcare management should promote the inclusion of healthcare professionals (nurses and doctors) with specific training in this type of unit and even promote learning courses for new professionals who join these units and become part of the multi-professional team. This situation would contribute within the NICUs to joint participation of the multidisciplinary team and the family.
• (3) The humanization within the NICUs should be addressed from the beginning by the professionals themselves, encouraging parental participation and giving meaning to the experiences of families. This situation can be carried out through the management area, respecting the shifts of the nursing that is found in these units.

5. Conclusions

Advances in hospital care have led to a new paradigm in the way of caring, in which the parents’ involvement in care and their permanent presence during medical and nursing procedures is considered beneficial for both the family and the newborn. This situation implies the need to establish individual rooms, each one with a bed, to offer the family rest. A common room for families is also promoted, which encourages the relationship between different families. In addition, this space is usually equipped for use during meals. Thus, for these families, the hospital stay can be maintained over time due to the economic savings that these measures represent.

However, there is still no general vision to apply this new way of working where the presence of parents is formalized 24 h a day. More training would be necessary for both the healthcare personnel and the family itself. Even health policies, such as health managers, should include improvements regarding space and trained personnel in these units. In addition, the presence of an intermediate command 24 h a day would be necessary to coordinate the health personnel with a unified turnaround where the routines facilitate the care of a neonate in a critical situation.

Therefore, it is verified that the patient and his/her family are recognized as the focus of attention. That nurses and doctors, as well as other professionals of the health team, must actively participate in humanized care. In addition, the patient and her/his family must be included in decision-making, and may even discuss the daily care plan and the expected results. This issue enhances family participation in the continuity of care when they are applied by the same professionals in their corresponding shifts within the NICUs. Even these professionals know the preferences of the newborn and the family for greater involvement in care. Therefore, care centered on the family and the newborn becomes safer, more efficient, effective, and timely.

Acknowledgments

We thank the staff of the Library of the University of Castilla-La Mancha, the Toledo campus (Arms Factory), for their invaluable assistance in collecting full-text articles.

List of Abbreviations

Author Contributions

Conceptualization, S.G.-C., I.G.-V., and M.D.-A.; methodology, I.G.-V., B.Y.-A., E.M.-M., and B.M.G.; formal analysis, B.Y.-A., E.M.-M., and M.D.-A.; investigation, S.G.-C., I.G.-V., B.M.G., E.M.-M., and B.Y.-A.; writing—original draft preparation, S.G.-C. and I.G.-V.; writing—review and editing, B.M.G., M.D.-A., and E.M.-M.; supervision, I.G.-V.; project administration, S.G.-C. and I.G.-V.; funding acquisition, S.G.-C. and B.M.G. All authors have read and agreed to the published version of the manuscript.

The ENDOCU Research Group, 2020-GRIN-29236 (Nursing, Pain, and Care), co-financed with European Regional Development Funds (ERDF) in the resolution of 19 February 2020 (DOCM 26 February 2020), of the University of Castilla-La Mancha, has subsidized this research.

Conflicts of Interest

The authors declare no conflict of interest.

Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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