Effectiveness of Simulation-based Training Delivered to Special Newborn Care Providers on Resuscitation Management and Kangaroo Mother Care: Simulation-based Training for Asyphxia in Babies Trial (STAR-Baby Trial) (STAR-Baby)

Effectiveness of Simulation-based Training Delivered to Special Newborn Care Providers on Resuscitation Management and Kangaroo Mother Care (STAR-Baby Trial)

Summary Background Neonatal mortality remains a major global public health challenge, with about 2.4 million newborn deaths occurring within the first month of life in 2020. Central and Southern Asia account for 36% of these deaths, with a neonatal mortality rate (NMR) of 23 per 1,000 live births. Birth asphyxia is a leading cause, responsible for nearly 900,000 deaths annually.

In Nepal, neonatal mortality has remained stagnant over the past decade, with an NMR of 21 per 1,000 live births in both 2016 and 2022. This is far above the national Sustainable Development Goal target of 12 per 1,000 by 2030. Despite initiatives such as the Every Newborn Action Plan, more than 80% of neonatal deaths are still due to preventable causes such as prematurity, birth asphyxia, and infections.

Although Nepal has expanded services through 61 Special Newborn Care Units (SNCUs), improvements in neonatal outcomes have been limited due to persistent gaps in quality of care and health worker skills. Studies highlight shortages of essential equipment, including neonatal resuscitation devices, and inadequate competency among providers, especially in managing non-breathing newborns. Provincial disparities further worsen outcomes and Lumbini provinces showing the highest NMRs. Poor facility readiness, lack of training, and limited availability of drugs and equipment contribute to suboptimal care. Hypothermia and inadequate Kangaroo Mother Care (KMC) practices also increase risks, particularly among low-birth-weight infants.

Simulation-based training has emerged as an effective strategy to strengthen healthcare providers' skills in neonatal resuscitation. Evidence from countries like Tanzania shows improved clinical performance and reduced neonatal complications. The NeoNatalie™ simulator, a low-cost and portable training tool, has been effective in enhancing providers' competence and confidence. In Nepal's context of limited resources and skill gaps, such training offers a practical and scalable solution to improve neonatal outcomes and accelerate progress toward SDG targets.

This study aims to evaluate the effectiveness of simulation-based training in improving the knowledge, skills, and performance of newborn care providers and reducing neonatal mortality in Nepal.

Methods The study is designed as a two-arm, parallel cluster randomized controlled trial conducted in SNCUs across Lumbini province of Nepal. Hospitals will serve as clusters, with equal allocation into intervention and control groups. Participants will include medical officers, nurses, and paramedics working in SNCUs for at least six months. A total of 240 providers (120 per arm) will be enrolled, accounting for clustering and potential attrition. Randomization will be conducted by an independent statistician, with allocation concealment ensured.

Intervention The intervention includes a three-day simulation-based training using the Helping Babies Breathe (HBB) program and NeoNatalie™ simulator. It covers essential newborn care, neonatal resuscitation within the "Golden Minute," breastfeeding, hypothermia prevention, KMC, and infection management. This will be followed by twelve months of mentoring and coaching by trained health workers. The control group will continue routine care.

Data collection and analysis Data will be collected using standardized tools and electronic systems, ensuring quality monitoring.

Data analysis will use appropriate statistical methods, including Analysis of Covariance (ANCOVA), to compare outcomes between groups. Ethical approval will be obtained from Nepal Health Research Council, and informed consent will be ensured. Data confidentiality and trial registration will also be maintained.

Study Management This study will be conducted in coordination with the Provincial Health Training Center, Provincial Health Directorate and provincial hospitals of Lumbini province and led by a team of experts in newborn health, research and epidemiology. Overall, this study addresses critical gaps in newborn care in Nepal by testing a context-specific, skill-based intervention. The study has the potential to improve provider performance, enhance quality of care, and significantly reduce preventable neonatal deaths in resource limited settings in Nepal and elsewhere globally.

Expected outcome and measures Key outcomes include provider knowledge, confidence, and clinical skills assessed through structured questionnaires and Objective Structured Clinical Examinations (OSCEs). These will measure both routine newborn care and management of non-breathing infants, along with KMC implementation.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypothermia Neonatal; Newborn Asphyxia
• Intervention / Treatment: Procedure: Simulation-based training using Neonatalie

Detailed Description

1. Background 1.1 Introduction Globally, neonatal mortality remains one of the most pressing public health concerns. In 2020, an estimated 2.4 million children died within the first month of life. Central and Southern Asia alone accounted for 36% of these deaths, with a neonatal mortality rate (NMR) of 23 per 1,000 live births . Birth asphyxia, classified as an intrapartum-related complication. The condition continues to be a major cause of neonatal death worldwide, responsible for nearly 900,000 deaths each year.

   In Nepal, neonatal mortality has remained stagnant over the past decade. Findings from the Nepal Demographic and Health Survey (NDHS) revealed that the NMR stood at 21 per 1,000 live births in both 2016 and 2022. This level of mortality is considerably higher than Nepal's Sustainable Development Goal (SDG) target, which aims to reduce NMR to 12 per 1,000 live births by 2030. The slow progress reflects systemic gaps in both service coverage and quality of care for mothers and newborns.

   Nepal's Every Newborn Action Plan outlines strategic interventions such as promotion of birth preparedness, essential newborn care, timely postnatal visits, effective management of non-breathing babies at birth, and care for preterm, low birth weight, and septic newborn. Despite these commitments, neonatal deaths in Nepal remain largely attributable to preventable and treatable conditions. More than 80% of newborn deaths result from three major causes: complications of prematurity, intrapartum-related causes (including birth asphyxia), and neonatal infections.

   1.2 Problem Statement Although Nepal has made progress in expanding newborn care services and establishing Special Newborn Care Units (SNCUs), the neonatal mortality rate has not declined in recent years. Currently, 61 SNCUs are functional across the country, but gaps remain in service quality and health worker competencies. Multiple assessments have identified shortages of essential equipment, such as bag and mask devices for neonatal resuscitation, in delivery rooms. Furthermore, studies show that many health workers lack adequate knowledge and practical skills in neonatal resuscitation, resulting in poor outcomes even in facility-based deliverie Geographic and provincial disparities exacerbate the problem. Lumbini provinces record the highest NMRs, at 24 per 1,000 live births. Analysis of the 2021 Nepal Health Facility Survey highlighted that Lumbini Province, in particular, performed poorly in facility readiness, staff training, and availability of essential drugs and equipment for neonatal care. This evidence indicates that existing maternal and child health interventions, while necessary, are insufficient to drive significant reductions in neonatal deaths, particularly from birth asphyxia, the second leading cause of neonatal mortality after sepsis. Further, hypothermia remains the problem of neonatal deaths in low-birth-weight babies and need health workers' expertise in Kangaroo Mother Care practices.

   1.3 Rationale Simulation-based training has emerged as an effective strategy to strengthen health workers' skills in neonatal resuscitation. Evidence from Tanzania demonstrated that such training significantly improved providers' clinical performance and reduced adverse perinatal outcomes Similarly, use of the NeoNatalie™ simulator, a low-cost, portable, and realistic manikin, which has been shown to enhance midwives' competence and motivation in neonatal resuscitation. In the Nepalese context, where neonatal mortality remains high, health facilities often lack adequate equipment, and providers demonstrate limited resuscitation skills, the integration of simulation-based training represents a timely and contextually relevant intervention. By building provider competence and confidence in managing birth asphyxia, simulation training has the potential to improve neonatal survival and accelerate progress toward Nepal's SDG target of reducing NMR to 12 per 1,000 live births by 2030. The low-birth-weight prevalence is around 12% in the country and they need to provide Kangaroo Mother Care (KMC) as well. However, the skill of health workers needs to be enhanced through simulator-based training and required indication of KMC. Therefore, this study aims to evaluate the effectiveness of simulation-based training to improve skills and performance of neonatal care service providers and reduce newborn mortality in Nepal.

2. Methods 2.1 Study Design and Settings This study is designed as a two-arm, parallel cluster randomized controlled trial (RCT) with an allocation ratio of 1:1. The trial will be conducted in Special Newborn Care Units (SNCUs) (including KMC units) located in Lumbini and Madhesh Provinces, Nepal. Clusters will be defined at the hospital level to minimize contamination across providers. 2.2 Inclusion and exclusion criteria All newborn care providers (medical officers, nurses, and paramedics) working in the selected SNCUs for at least six months prior to baseline assessment. Providers who are on long-term leave or those not directly engaged in newborn care at the SNCU. 2.3 Sample Size Using a two-sample comparison of means (two-sided α=0.05, 90% power), with σ=1.6 (KC A. et al. 2017) and Δ=1.0, the individually randomized per-arm sample size is 54. Applying a design effect DEFF=2.0 to account for clustering at the hospital/SNCU level and inflating by 10% for attrition yields 120 providers per arm (total N=240). With 12 hospitals (6 per arm), the average cluster size is m=20 providers/SNCU, which implies an ICC of approximately 0.053. Recruitment targets are therefore 20 eligible providers per SNCU (six SNCU each in each arm) to achieve the required power.

2.4 Randomization and allocation concealment Random allocation of the 12 SNCUs into intervention and control arms will be performed by an independent statistician using a computer-generated random sequence. Allocation results will be concealed in sealed opaque envelopes. At a study design workshop with the Ministry of Health and Population (MoHP) and the national maternal and neonatal technical working group, the envelopes will be opened by the group chair to assign hospitals to trial arms.

2.5 Experimental Design

The intervention consists of a structured simulation-based training program using the Helping Babies Breathe (HBB) package and the NeoNatalie™ simulator:

• Training: Three-day simulation-based training delivered by certified neonatologists/pediatricians with SNCU/NICU experience. Training covers preparation of the birthing unit, routine newborn care, neonatal resuscitation (within the "Golden Minute"), breastfeeding initiation, Kangaroo Mother Care (KMC), hypothermia prevention, feeding of low-birth-weight infants, and sepsis recognition and management.
• Follow-up support: Monthly mentoring and coaching sessions for six months post-training, led by neonatologists/pediatricians and nurses trained in simulation-based care.
• Control arm: Facilities continue providing routine newborn care services without additional intervention.

2.6 Study variables

Independent variables:

• Sociodemographic characteristics of providers (age, sex, academic qualifications).
• Work-related characteristics (number of deliveries conducted, previous training, duration of SNCU experience).
• Facility readiness (availability of drugs, equipment, and guidelines).

Outcome variables:

1. Knowledge and confidence in essential delivery and newborn care, measured through structured questionnaires.
2. Skills in neonatal resuscitation assessed using Objective Structured Clinical Examinations (OSCEs) aligned with HBB protocols:
3. OSCE A: Routine care of a healthy newborn (drying, warming, airway clearance, delayed cord clamping, breastfeeding initiation).
4. OSCE B: Management of a non-breathing newborn (airway positioning, bag-mask ventilation, chest rise recognition, heart rate assessment, communication with mother).
5. Implementation of Kangaroo Mother Care (KMC) for low-birth-weight infants. 2.7 Data Collection

Data collectors (a medical officer and a nurse/paramedic trained in SNCU practices) will be trained in data quality assurance and ethical procedures by the principal investigator (PI) and neonatologist co- investigator. Data collection tools include:

• Facility assessment checklists,
• Structured provider questionnaires, and
• OSCE performance checklists using the NeoNatalie™ simulator. Data will be captured electronically using KoBo Toolbox. Monitoring and supervision will be conducted by the PI, co-investigators, and a field manager, with real-time feedback provided to the field teams.

2.8 Data Analysis Comparisons between trial arms will be conducted using appropriate statistical tests based on type of variables. Knowledge and confidence scores will be analyzed as continuous outcomes, while OSCE results will be summarized both by item and as composite scores. Facility readiness will be assessed across domains (guidelines and training, equipment, essential medicines) and reported as summary readiness indices. Anvalysis of Covariance (ANCOVA) will be done for the continuous outcome with prespecified covariates. All analyses will be performed in R software (version 4.4, R Foundation for Statistical Computing, Vienna, Austria). Statistical significance will be defined as p < 0.05.

2.9 Ethical consideration Ethical approval will be obtained from the Nepal Health Research Council (NHRC). Informed consent will be secured from all participating health workers. Data confidentiality will be ensured through use of coded identifiers and secure storage. The trial will be preregistered in National Library of Medcinie's clinical trial registry (https://clinicaltrials.gov/).

3. Study Management This study will be conducted in coordination with the Provincial Health Training Center, Provincial Health Directorate and provincial hospitals of Lumbini province. Dr. Khem Pokhrel, an experienced neonatal health researcher in Nepal, will lead the overall process as the Principal Investigator. The training and intervention components will be led by Dr. Santhosh, a specialist neonatologist and master trainer for newborn care, while Ms. Apsara Pandey, Associate Professor of Neonatology at the Institute of Medicine, will oversee nursing procedures. Mr. Suman Sapkota, an epidemiologist, will be responsible for study design and data analysis. Ministry of Health and Population will ensure the quality assurance of the study.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khem Narayan Pokhrel, PhD; Phone Number: 9779851113827; Email: pokhrelkhemn@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Newborn care providers who have received Skilled Birth Attendant Training
• Newborn care providers who have worked in Special Newborn Care Unit at least six months of period

Exclusion Criteria:

• Newborn care providers who have not provided newborn care at special newborn care
• Not willing to participate
• Short tem contract (less than six months of working period)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SNCUs with Simulation-based Asphyxia Management and Kangaroo Mother Care Training; The arm consists of sepcial newborn care units in Lumbini province. In this arm, 120 health workers will be trained using simulation-based asphixia management modules and and traning for Kangaroo Mother Training. The training will be 4 days training followed by monthly mentoring and coaching by the trained neonatal service providers.	Procedure: Simulation-based training using Neonatalie; The intervention consists of a structured simulation-based training program using the Helping Babies Breathe (HBB) package and the NeoNatalie™ simulator: • Training: Four-day simulation-based training delivered by certified neonatologists/pediatricians with SNCU/NICU experience. Training covers preparation of the birthing unit, routine newborn care, neonatal resuscitation (within the "Golden Minute"), breastfeeding initiation, Kangaroo Mother Care (KMC), hypothermia prevention, feeding of low-birth-weight infants, and sepsis recognition and management. Further, the staff in the SNCUs will be provided monthly mentoring and coaching at the site for 12 months.; Other Names: Kangaroo Mother Care; Coaching and Mentoring at hospital; Helping Baby Breathe
No Intervention: SNCUs where staff are not receiving simulation-based training and providing usual care; SNCU facitities will continue providing routine newborn care services. The staff in the facilities will not be provided training from the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge and Confidence on Resucitation Management	1. Health worker's knowledge and confidence on resuscitation management will be measured using 24 items scale. One itme carries the score of "1" The highest score will be 24 and lowest will be 0.	12 months
2. Skill and performance of newborn care providers on asphyxia managmeent will be assessed using objective structured clinicical examination (OSCE) scale.	Skills and performance of newborn of the neworn care providers will be measured using 22 items scale. one item carries a score of "1" The lowest score is 0 and the highest score is 22.This will consists of the measurement of the normal baby and asphxiated baby. The assessement assesses the prepration, resusciation management, and support.	12 months
Kangaroo Mother Care Practices	Helath Workers will be provided training on Kangaroo Mother Care Practices among Low-birth-weight baby. This skills will support health workers to manage hypothermia	12 months

Collaborators and Investigators

• Sponsor: Integrated Development Foundation Nepal
• Collaborators: Health Nutrition Education and Agriculture Research Development Nepal; Laerdal Foundation, Norway; Development and Research Service International Nepal

Publications and helpful links

General Publications

• Lama TP, Munos MK, Katz J, Khatry SK, LeClerq SC, Mullany LC. Assessment of facility and health worker readiness to provide quality antenatal, intrapartum and postpartum care in rural Southern Nepal. BMC Health Serv Res. 2020 Jan 6;20(1):16. doi: 10.1186/s12913-019-4871-x.
• Ministry of Health. Government of Nepal. (2016). Nepal's Every Newborn Action Plan.
• Erchick DJ, Lackner JB, Mullany LC, Bhandari NN, Shedain PR, Khanal S, Dhakwa JR, Katz J. Causes and age of neonatal death and associations with maternal and newborn care characteristics in Nepal: a verbal autopsy study. Arch Public Health. 2022 Jan 11;80(1):26. doi: 10.1186/s13690-021-00771-5.
• Kc A, Singh DR, Upadhyaya MK, Budhathoki SS, Gurung A, Malqvist M. Quality of Care for Maternal and Newborn Health in Health Facilities in Nepal. Matern Child Health J. 2020 Feb;24(Suppl 1):31-38. doi: 10.1007/s10995-019-02846-w.
• Ministry of Health and Population [Nepal], New ERA, and ICF. (2023). Nepal Demographic and Health Survey 2022. Kathmandu, Nepal: Ministry of Health and Population [Nepal].
• Governement of Nepal. National Planning Commission. (2018). Sustainable Development Goals, Status and Roadmap_ 2016-2030.
• Wrammert J, Zetterlund C, Kc A, Ewald U, Malqvist M. Resuscitation practices of low and normal birth weight infants in Nepal: an observational study using video camera recordings. Glob Health Action. 2017;10(1):1322372. doi: 10.1080/16549716.2017.1322372.
• Pokhrel KN, Khatri R, Sapkota S, Pokhrel KG, Pradhan G, Thapa TR, Chapain KP, Pullum T, Greenwell F. Elucidating trends and underlying drivers of neonatal mortality stagnation in Nepal: An analytical perspective on the 2016 and 2022 Demographic and Health Surveys. PLoS One. 2025 Aug 22;20(8):e0330734. doi: 10.1371/journal.pone.0330734. eCollection 2025.
• Vadla MS, Mdoe P, Moshiro R, Haug IA, Gomo O, Kvaloy JT, Oftedal B, Ersdal H. Neonatal Resuscitation Skill-Training Using a New Neonatal Simulator, Facilitated by Local Motivators: Two-Year Prospective Observational Study of 9000 Trainings. Children (Basel). 2022 Jan 20;9(2):134. doi: 10.3390/children9020134.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: April 4, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Nepal; Simulation-based training; Cluster Randomized Controlled Trial; Kangaroo Mother Care; Newborn Ashyxia; Resuscitation Management; Special Newborn Care Unit
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Asphyxia Neonatorum; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Infant Care; Child Care; Patient Positioning; Kangaroo-Mother Care Method
• Other Study ID Numbers: IDFNepal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The protocol will be shared with the formal request to the principal investigator.
• IPD Sharing Time Frame: May 2028-July 2028
• IPD Sharing Access Criteria: The request should come from formal email.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No