The Ethiopian National Immunization Technical Advisory Group (E-NITAG): Establishment, Achievements and the Future.

The National Immunization Program (NIP) was introduced in Ethiopia in 1980. The NIP has expanded the number of vaccines from six to more than 14 in 2023. However, decisions on new vaccine introduction and other vaccine-related matters were not systematically deliberated nationally. Thus, the need to establish a national body to deliberate on vaccine and vaccination matters, in addition to the global immunization advisory groups, has been emphasized in the last decade. This article presents the establishment and achievements of the Ethiopian NITAG. The E-NITAG was established in 2016 and maintained its active role in providing recommendations for new vaccine introduction and improving the delivery of routine vaccines. The external assessment indicated the E-NITAG was highly functional and played a critical role in enhancing the vaccination practice in Ethiopia, especially during the COVID-19 pandemic. The absence of a dedicated secretariat staff was the major bottleneck to expanding the role of the E-NITAG beyond responding to MOH requests. The E-NITAG must be strengthened by establishing a secretariat that can eventually grow as an independent institution to address complex vaccine-related issues the NIP needs to address.

High inter-rater reliability between physicians and nurses utilising modified Downes' scores in preterm respiratory distress.

AIM: To assess the inter-rater reliability of modified Downes' scores assigned by physicians and nurses in the Ethiopian Neonatal Network and to calculate the concordance of score-based treatment for preterm infants with respiratory distress. METHODS: We included preterm infants admitted from June 2020 to July 2021 to four tertiary neonatal intensive care units (NICUs) of the Ethiopian Neonatal Network that presented with respiratory distress. We calculated the kappa statistic to determine the nurse and physician correlation for each component of the modified Downes' score and total score on admission and evaluated the concordance of scores above and below the treatment threshold of 4. RESULTS: Of the 1151 eligible infants admitted, 817 infants (71%) had scores reported concurrently and independently by nurse and physician. The kappa statistic for modified Downes' score components ranged from 0.88 to 0.92 and was 0.89 for the total score. There was 98% concordance for score-based treatment. CONCLUSION: Incorporation of the modified Downes' score on admission for preterm infants with respiratory distress was feasible in tertiary NICUs in Ethiopia. The kappa statistics showed near-perfect agreement between nurse and physician assessments, translating to a very high degree of concordance in score-based treatment recommendations. These results highlight an opportunity for task-shifting assessments and empowering nurses.

The Journey Toward Establishing Inpatient Care for Small and Sick Newborns in Ethiopia, India, Malawi, and Rwanda.

BACKGROUND: Limited information is available about the approaches used and lessons learned from low- and middle-income countries that have implemented inpatient services for small and sick newborns. We developed descriptive case studies to compare the journeys to establish inpatient newborn care across Ethiopia, India, Malawi, and Rwanda. METHODS: A total of 57 interviews with stakeholders in Ethiopia (n=12), India (n=12), Malawi (n=16), and Rwanda (n=17) informed the case studies. Our heuristic data analysis followed a deductive organizing framework approach. We informed our data analysis via targeted literature searches to uncover details related to key events. We used the NEST360 Theory of Change for facility-based care, which reflects the World Health Organization (WHO) Health Systems Framework as a starting point and added, as necessary, in an edit processing format until data saturation was achieved. FINDINGS: Results highlight the strategies and innovation used to establish small and sick newborn care by health system building block and by country. We conducted a gap analysis of implementation of WHO Standards for Improving Facility-Based Care. The journeys to establish inpatient newborn care across the 4 countries are similar in terms of trajectory yet unique in their implementation. Unifying themes include leadership and governance at national level to consolidate and coordinate action to improve newborn quality of care, investment to build staff skills on data collection and use, and institutionalization of regular neonatal data reviews to identify gaps and propose relevant strategies. CONCLUSION: Efforts to establish and scale inpatient care for small and sick newborns in Ethiopia, India, Malawi, and Rwanda over the last decade have led to remarkable success. These country examples can inspire more nascent initiatives that other low- and middle-income countries may undertake. Documentation should give voice to lived country experience, not all of which is fully captured in existing, peer-reviewed published literature.

Development and evaluation of a kangaroo mother care implementation model in South Ethiopia.

AIM: To develop a model for increasing the coverage of kangaroo mother care (KMC), which involved ≥8 h of skin-to-skin contact per day and exclusive breastfeeding, for small babies with birth weight < 2000 g in South Ethiopia. METHODS: A mixed methods study was conducted between June 2017 and January 2019 at four hospitals and their catchment areas. Iterative cycles of implementation, program learning and evaluation were used to optimise KMC implementation models. The study explored the community-facility continuum of care and assessed the proportion of neonates with a birth weight less than 2000 g receiving effective KMC. RESULTS: Three KMC implementation models were tested with Model 2 being the final version. This model included enhanced identification of home births, improved referral linkages, immediate skin-to-skin care initiation in facilities and early contact after discharge. These improvements resulted in 86% coverage of effective facility-based KMC initiation for eligible babies. The coverage was 81.5% at discharge and 57.5% 7 days after discharge. The mean age of babies at KMC initiation was 8.2 days (SD = 5.7). CONCLUSION: The study found that the KMC implementation model was feasible and can lead to substantial population-level KMC coverage for small babies.

Recent Progress in Neonatal Global Health Quality Improvement.

Quality improvement methodologies, coupled with basic neonatal resuscitation and essential newborn care training, have been shown to be critical ingredients in improving neonatal mortality. Innovative methodologies, such as virtual training and telementoring, can enable the mentorship and supportive supervision that are essential to the continued work of improvement and health systems strengthening that must be done after a single training event. Empowering local champions, building effective data collection systems, and developing frameworks for audits and debriefs are among the strategies that will create effective and high-quality health care systems.

Common perinatal mental disorders and post-infancy child development in rural Ethiopia: A population-based cohort study.

OBJECTIVE: To investigate whether maternal common mental disorders (CMD) in the postnatal period are prospectively associated with child development at 2.5 and 3.5 years in a rural low-income African setting. METHODS: This study was nested within the C-MaMiE (Child outcomes in relation to Maternal Mental health in Ethiopia) population-based cohort in Butajira, Ethiopia, and conducted from 2005 to 2006. The sample comprised of 496 women who had recently given birth to living, singleton babies with recorded birth weight measurements, who were 15 to 44 years of age, and residing in six rural sub-districts. Postnatal CMD measurements were ascertained 2 months after delivery. Language, cognitive, and motor development were obtained from the child 2.5 and 3.5 years after birth using a locally adapted version of the Bayley Scales of Infant Development (3rd Ed). Maternal CMD symptoms were measured using a locally validated WHO Self-Reporting Questionnaire. A linear mixed-effects regression model was used to analyze the relationship between postnatal CMD and child development. RESULTS: After adjusting for confounders, there was no evidence for an association between postnatal CMD and overall child development or the cognitive sub-domain in the preschool period. There was no evidence of effect modification by levels of social support, socioeconomic status, stunting, or sex of the child. CONCLUSIONS: Previous studies from predominantly urban and peri-urban settings in middle-income countries have established a relationship between maternal CMD and child development, which contrasts with the findings from this study. The risk and protective factors for child development may differ in areas characterized by high social adversity and food insecurity. More studies are needed to investigate maternal CMD's impact on child development in low-resource and rural areas.

Antenatal Steroid Utilization in Ethiopia.

Background. Administration of antenatal corticosteroids to pregnant mothers is one of the most effective interventions to decrease preterm neonatal mortality. In this study we assessed antenatal steroid utilization by the mother and its effect on preterm babies. Method. Two years prospective, multicenter, observational study was conducted in selected hospitals of Ethiopia. Significance of the study outcomes was tested by chi-square and binary logistic regression. Result. Out of 4919 participants, 1575 preterm babies whose gestational ages were below 35 weeks were included in the study. Use of antenatal dexamethasone was 37.5% among study participants. The risk of early onset neonatal sepsis 235 (40.4%) was higher in preterm babies whose mother took antenatal dexamethasone (P-value .002) than those who did not. Conclusion. Antenatal dexamethasone use in our study was comparable with other low and middle-income countries. Risk of early onset neonatal sepsis was higher among infants whose mother took antenatal dexamethasone.

Barriers for kangaroo mother care (KMC) acceptance, and practices in southern Ethiopia: a model for scaling up uptake and adherence using qualitative study.

BACKGROUND: Globally, approximately 15 million babies are born preterm every year. Complications of prematurity are the leading cause of under-five mortality. There is overwhelming evidence from low, middle, and high-income countries supporting kangaroo mother care (KMC) as an effective strategy to prevent mortality in both preterm and low birth weight (LBW) babies. However, implementation and scale-up of KMC remains a challenge, especially in lowincome countries such as Ethiopia. This formative research study, part of a broader KMC implementation project in Southern Ethiopia, aimed to identify the barriers to KMC implementation and to devise a refined model to deliver KMC across the facility to community continuum. METHODS: A formative research study was conducted in Southern Ethiopia using a qualitative explorative approach that involved both health service providers and community members. Twenty-fourin-depth interviewsand 14 focus group discussions were carried out with 144study participants. The study applied a grounded theory approach to identify,examine, analyse and extract emerging themes, and subsequently develop a model for KMC implementation. RESULTS: Barriers to KMC practice included gaps in KMC knowledge, attitude and practices among parents of preterm and LBW babies;socioeconomic, cultural and structural factors; thecommunity's beliefs and valueswith respect to preterm and LBW babies;health professionals' acceptance of KMC as well as their motivation to implement practices; and shortage of supplies in health facilities. CONCLUSIONS: Our study suggests a comprehensive approach with systematic interventions and support at maternal, family, community, facility and health care provider levels. We propose an implementation model that addresses this community to facility continuum.

Ethiopian Pediatric Society Quality Improvement Initiative: a pragmatic approach to facility-based quality improvement in low-resource settings.

OBJECTIVES: To describe critical features of the Ethiopian Pediatric Society (EPS) Quality Improvement (QI) Initiative and to present formative research on mentor models. SETTING: General and referral hospitals in the Addis Ababa area of Ethiopia. PARTICIPANTS: Eighteen hospitals selected for proximity to the EPS headquarters, prior participation in a recent newborn care training cascade and minimal experience with QI. INTERVENTIONS: Education in QI in a 2-hour workshop setting followed by implementation of a facility-based QI project with the support of virtual mentorship or in-person mentorship. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome-QI progress, measured using an adapted Institute for Healthcare Improvement Scale; secondary outcome-contextual factors affecting QI success as measured by the Model for Understanding Success in Quality. RESULTS: The dose and nature of mentoring encounters differed based on a virtual versus in-person mentoring approach. All QI teams conducted at least one large-scale change. Education of staff was the most common change implemented in both groups. We did not identify contextual factors that predicted greater QI progress. CONCLUSIONS: The EPS QI Initiative demonstrates that education in QI paired with external mentorship can support implementation of QI in low-resource settings. This pragmatic approach to facility-based QI may be a scalable strategy for improving newborn care and outcomes. Further research is needed on the most appropriate instruments for measuring contextual factors in low/middle-income country settings.

Incidence and associated factors of extrauterine growth restriction (EUGR) in preterm infants, a cross-sectional study in selected NICUs in Ethiopia.

BACKGROUND: Preterm infants have high risk of developing growth restriction and long-term complications. Enteral feeding is often delayed in neonatal intensive care units (NICUs) for the fear of feeding intolerance and the associated necrotising enterocolitis, and recent advances in nutritional support are unavailable in low-income countries. OBJECTIVE: The aim of this study was to assess the incidence and associated factors of extrauterine growth restriction (EUGR) among preterm infants in selected NICUs in Ethiopia. METHOD: This was a cross-sectional study involving a subgroup analysis of preterm infants admitted to hospitals, from a multicentre descriptive study of cause of illness and death in preterm infants in Ethiopia, conducted from 2016 to 2018. EUGR was defined as weight at discharge Z-scores <-1.29 for corrected age. Clinical profiles of the infants were analysed for associated factors. SPSS V.23 software was used for analysis with a significance level of 5% and 95% CI. RESULT: From 436 preterm infants included in the analysis, 223 (51%) were male, 224 (51.4%) very low birth weight (VLBW) and 185 (42.4%) small for gestational age (SGA). The mean (SD) of weight for corrected age Z-score at the time of discharge was -2.5 (1.1). The incidence of EUGR was 86.2%. Infants who were SGA, VLBW and longer hospital stay over 21 days had increased risk of growth restriction (p-value<0.01). SGA infants had a 15-fold higher risk of developing EUGR at the time of discharge from hospital than those who were appropriate or large for gestational age (OR (95% CI)=15.2 (4.6 to 50.1). CONCLUSION: The majority of the infants had EUGR at the time of discharge from the hospital, which indicates suboptimal nutrition. Revision of national guidelines for preterm infants feeding and improvement in clinical practice is highly required.

Helping Babies Survive Programs as an Impetus for Quality Improvement.

Achieving the ambitious reduction in global neonatal mortality targeted in the Sustainable Development Goals and Every Newborn Action Plan will require reducing geographic disparities in newborn deaths through targeted implementation of evidence-based practices. Helping Babies Survive, a suite of educational programs targeting the 3 leading causes of neonatal mortality, has been commonly used to educate providers in evidence-based practices in low-resource settings. Quality improvement (QI) can play a pivotal role in translating this education into improved care. Measurement of key process and outcome indicators, derived from the algorithms ("Action Plans") central to these training programs, can assist health care providers in understanding the baseline quality of their care, identifying gaps, and assessing improvement. Helping Babies Survive has been the focus of QI programs in Kenya, Nepal, Honduras, and Ethiopia, with critical lessons learned regarding the challenge of measurement, necessity of facility-based QI mentorship and multidisciplinary teams, and importance of systemic commitment to improvement in promoting a culture of QI. Complementing education with QI strategies to identify and close remaining gaps in newborn care will be essential to achieving the Sustainable Development Goals and Every Newborn Action Plan targets in the coming decade.

Bacterial Isolates and Resistance Patterns in Preterm Infants with Sepsis in Selected Hospitals in Ethiopia: A Longitudinal Observational Study.

Background: Neonatal sepsis is the third leading cause of neonatal mortality, behind prematurity and intrapartum-related complications. The main objectives of this study are to assess the proportion of sepsis in preterm newborns and identify the etiologic agents and their antibiotic sensitivity patterns. Methods: A longitudinal observational study was done from July 2016 to May 2018. Whenever clinical diagnosis of sepsis was made, blood cultures and antibiotic susceptibility tests were done. Result: We did 690 blood cultures, 255 (36.9%) showing bacterial growth. The most commonly isolated bacteria were Klebsiella species 78 (36.6%), Coagulase negative Staphylococcus 42 (19.7%) and Staphylococcus aureus 39 (18.3%). Gram-positive bacteria showed high resistance to penicillin (98.9%) and ceftriaxone (91.3%) whereas Gram-negative bacteria were highly resistant to gentamicin (83.2%) and ceftriaxone (83.2%). Conclusion: Resistance to the more commonly used antibiotics such as ampicillin and gentamycin was very high, necessitating reconsideration of the empiric use of these antibiotics.

Hematologic Profiles of Ethiopian Preterm Infants With Clinical Diagnoses of Early-Onset Sepsis, Perinatal Asphyxia, and Respiratory Distress Syndrome.

Objective. To determine the hematologic profile of preterm infants with regard to different diseases. Methods. A prospective, cross-sectional, observational study, conducted in 5 hospitals in Ethiopia from July 2016 to May 2018. Preterm babies <7 days of age were included and investigated with complete blood counts (CBC) and other investigations, accordingly. Results. Out of 4919 preterms, 3852 (78.3%) were admitted to a newborn intensive care unit, and of these, 68.3% had a CBC performed. The mean values of hemoglobin, white blood cell (WBC) and platelet counts were 17.9 mg/dL; 12 685 cells/mm3, and 159 340 cells/mm3, respectively. Early onset neonatal sepsis (EONS) 1433 (37%), asphyxia 266 (6.9%), and respiratory distress syndrome (RDS) 1738 (45.3%) were common reasons for admission. The WBC count was <5000 cells/mm3 for 8.8%, 9.0%, and 11.1% of neonates with EONS, asphyxia and RDS, respectively. The hemoglobin value was <7 mg/dL for 0.6%, 1.7%, and 0.4% of preterm infants with EONS, asphyxia, and RDS, respectively. The platelet count was <50 000 cells/mm3 for 16.8%, 17.7%, and 19.8% of preterms admitted with a diagnosis of EONS, asphyxia, and RDS, respectively. Conclusion. WBC and platelet counts were the most common to be associated with EONS, asphyxia, and RDS. Further study is recommended to determine the effect of abnormal hematologic profile on the outcome of preterm babies.

Hypothermia in Preterm Newborns: Impact on Survival.

Background. Globally, prematurity is the leading cause of neonatal mortality, and hypothermia is one of its contributing factors. The goal of this study was to determine the association between hypothermia and mortality. Methods. A prospective, multi-center, descriptive clinical study was conducted in 5 hospitals in Ethiopia. Axillary temperatures were taken at the time of admission to the newborn intensive care units (NICU) and followed during the NICU stay. Results. A total of 3852 premature neonates (<37 weeks) were admitted to the NICUs from July 2016 to May 2018. Of these infants, 1109 (28.8%) died and 2991 (79.6%) had hypothermia. Hypothermia was associated with perinatal asphyxia (89.5%), RDS (86.2%), and resuscitation at birth (82.7%). Admission temperatures in preterm newborns were inversely associated with mortality and morbidity. Conclusion. Hypothermia at admission is associated with neonatal mortality in premature neonates in Ethiopia. RDS and perinatal asphyxia were the main factors associated with hypothermia. The very high prevalence and association with mortality warrants quality improvement interventions.

Comparison of neonatal outcomes of small for gestational age and appropriate for gestational age preterm infants born at 28-36 weeks of gestation: a multicentre study in Ethiopia.

PURPOSE: The aim of this study was to assess morbidity and mortality pattern of small for gestational age (SGA) preterm infants in comparison to appropriate for gestational age (AGA) preterm infants of similar gestational age. METHOD: We compared neonatal outcomes of 1336, 1:1 matched, singleton SGA and AGA preterm infants based on their gestational age using data from the study 'Causes of Illness and Death of Preterm Infants in Ethiopia (SIP)'. Data were analysed using SPSS V.23. ORs and 95% CIs and χ2 tests were done, p value of <0.05 was considered statistically significant. RESULT: The majority of the infants (1194, 89%) were moderate to late preterm (32-36 weeks of gestation), 763 (57%) were females. Male preterm infants had higher risk of being SGA than female infants (p<0.001). SGA infants had increased risk of hypoglycaemic (OR and 95% CI 1.6 (1.2 to 2.0), necrotising enterocolitis (NEC) 2.3 (1.2 to 4.1), polycythaemia 3.0 (1.6 to 5.4), late-onset neonatal sepsis (LOS) 3.6 (1.1 to 10.9)) and prolonged hospitalisation 2.9 (2.0 to 4.2). The rates of respiratory distress syndrome (RDS), apnoea and mortality were similar in the SGA and AGA groups. CONCLUSION: Neonatal complications such as hypoglycaemic, NEC, LOS, polycythaemia and prolonged hospitalisation are more common in SGA infants, while rates of RDS and mortality are similar in SGA and AGA groups. Early recognition of SGA status, high index of suspicion and screening for complications associated and timely intervention to prevent complications need due consideration.

Preterm Nutrition and Clinical Outcomes.

Background. In low-income countries, preterm nutrition is often inadequately addressed. The aim of the study was to assess the patterns of feeding and associated clinical outcomes of preterm neonates admitted to neonatal intensive care units in Ethiopia. Method. This was a multicenter, prospective study. Infants' clinical characteristics at birth, daily monitoring of feeding history, and weight measurements were collected. An outcome assessment was completed at 28 days. Result. For this analysis, 2560 infants (53% male) were eligible. The mean (SD) gestational age was 33.1 (2.2) weeks. During the hospital stay the proportion of infants on breast milk only, preterm formula, term formula, and mixed feeding was 58%, 27.4%, 1.6%, and 34.1%, respectively. Delay in enteral feeding was associated with increased risk of death (odds ratio [OR] = 1.92, 95% confidence interval [CI] = 1.33-2.78; P < .001) and (OR = 5.06, 95% CI = 3.23-7.87; P < .001) for 1 to 3 and 4 to 6 days of delay in enteral feeding, respectively, after adjusting for possible confounders. The length of delay in enteral feeding was associated with increased risk of hypoglycemia (OR = 1.2, 95% CI = 1.1-1.2; P = .005). The mortality rate was lower in hospitals providing preterm formula more often (P = .04). Half of the infants continued losing weight at the time of discharge. Conclusion. Delayed enteral feeding significantly increases the risk of mortality before discharge and hypoglycemia in preterm infants in resource-limited settings. Ensuring adequate nutritional support of preterm infants is highly needed.

Hyperbilirubinemia in Preterm Infants Admitted to Neonatal Intensive Care Units in Ethiopia.

Background. Hyperbilirubinemia is prevalent and protracted in preterm infants. This study assessed the pattern of hyperbilirubinemia in preterm infants in Ethiopia. Methods. This study was part of multi-centered prospective, cross-sectional, observational study that determined causes of death among preterm infants. Jaundice was first identified based on clinical visual assessment. Venous blood was then sent for total and direct serum bilirubin level measurements. For this study, a total serum bilirubin level ≥5 mg/dL was taken as the cutoff point to diagnose hyperbilirubinemia. Based on the bilirubin level and clinical findings, the final diagnoses of hyperbilirubinemia and associated complications were made by the physician. Result. A total of 4919 preterm infants were enrolled into the overall study, and 3852 were admitted to one of the study's newborn intensive care units. Of these, 1779 (46.2%) infants were diagnosed with hyperbilirubinemia. Ten of these (0.6%) developed acute bilirubin encephalopathy. The prevalence of hyperbilirubinemia was 66.7% among the infants who were less than 28 weeks of gestation who survived. Rh incompatibility (P = .002), ABO incompatibility (P = .0001), and sepsis (P = .0001) were significantly associated with hyperbilirubinemia. Perinatal asphyxia (P-value = 0.0001) was negatively associated with hyperbilirubinemia. Conclusion. The prevalence of hyperbilirubinemia in preterm babies admitted to neonatal care units in Ethiopia was high. The major risk factors associated with hyperbilirubinemia in preterm babies in this study were found to be ABO incompatibility, sepsis, and Rh isoimmunization.

Helping Babies Survive Training Programs: Evaluating a Teaching Cascade in Ethiopia.

BACKGROUND: 2.6 million neonates die annually; the vast majority of deaths occur in low- and middle-income countries (LMICs). The Helping Babies Survive (HBS) programs are commonly used in LMICs to reduce neonatal mortality through education. They are typically disseminated using a train-the-trainer cascade. However, there is little published literature on the extent and cost of dissemination. In 2015, the Ethiopian Ministry of Health and partner organizations implemented a countrywide HBS training cascade for midwives in 169 hospitals. METHODS: We quantified the extent of HBS dissemination, and characterized barriers that impeded successful hospital-based training by surveying a representative from each of the 169 participant hospitals. This occurred from September 2017 to April 2018. We also assessed the cost of the training cascade. To assess acquisition of knowledge and skill in the training cascade, multiple-choice question examinations (MCQE) and objective structured clinical evaluations (OSCE) were conducted. RESULTS: Hospital-based training occurred in 132 participant hospitals (78%). 1,146 midwives, 69% of those employed by participant hospitals, received hospital-based training. Barriers included lack of preparation of hospital-based educators and limited logistical support. The cascade cost an average of 2,105 USD per facility or 197 USD per trainee. Knowledge improved and skills were adequate for regional workshop attendees based on MCQE and OSCE performance. CONCLUSION: The train-the-trainer strategy is an effective and affordable strategy for widespread dissemination of the HBS programs in LMICs. Future studies should assess knowledge and skill acquisition following the variety of pragmatic training approaches that may be employed at the facility-level.

Kangaroo Mother Care implementation research to develop models for accelerating scale-up in India and Ethiopia: study protocol for an adequacy evaluation.

INTRODUCTION: Kangaroo Mother Care (KMC) is the practice of early, continuous and prolonged skin-to-skin contact between the mother and the baby with exclusive breastfeeding. Despite clear evidence of impact in improving survival and health outcomes among low birth weight infants, KMC coverage has remained low and implementation has been limited. Consequently, only a small fraction of newborns that could benefit from KMC receive it. METHODS AND ANALYSIS: This implementation research project aims to develop and evaluate district-level models for scaling up KMC in India and Ethiopia that can achieve high population coverage. The project includes formative research to identify barriers and contextual factors that affect implementation and utilisation of KMC and design scalable models to deliver KMC across the facility-community continuum. This will be followed by implementation and evaluation of these models in routine care settings, in an iterative fashion, with the aim of reaching a successful model for wider district, state and national-level scale-up. Implementation actions would happen at three levels: 'pre-KMC facility'-to maximise the number of newborns getting to a facility that provides KMC; 'KMC facility'-for initiation and maintenance of KMC; and 'post-KMC facility'-for continuation of KMC at home. Stable infants with birth weight<2000 g and born in the catchment population of the study KMC facilities would form the eligible population. The primary outcome will be coverage of KMC in the preceding 24 hours and will be measured at discharge from the KMC facility and 7 days after hospital discharge. ETHICS AND DISSEMINATION: Ethics approval was obtained in all the project sites, and centrally by the Research Ethics Review Committee at the WHO. Results of the project will be submitted to a peer-reviewed journal for publication, in addition to national and global level dissemination. STUDY STATUS: WHO approved protocol: V.4-12 May 2016-Protocol ID: ERC 2716. Study implementation beginning: April 2017. Study end: expected March 2019. TRIAL REGISTRATION NUMBER: Community Empowerment Laboratory, Uttar Pradesh, India (ISRCTN12286667); St John's National Academy of Health Sciences, Bangalore, India and Karnataka Health Promotion Trust, Bangalore, India (CTRI/2017/07/008988); Society for Applied Studies, Delhi (NCT03098069); Oromia, Ethiopia (NCT03419416); Amhara, SNNPR and Tigray, Ethiopia (NCT03506698).