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)

NCT07574944 | Not Yet Recruiting DMC

• 1 other identifier: IDFNepal
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Newborn Asphyxia; Hypothermia Neonatal

Keywords

Newborn Ashyxia; Resuscitation Management; Kangaroo Mother Care; Cluster Randomized Controlled Trial; Nepal; Special Newborn Care Unit; Simulation-based training

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

SNCUs with Simulation-based Asphyxia Management and Kangaroo Mother Care Training

EXPERIMENTAL

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

SNCUs where staff are not receiving simulation-based training and providing usual care

NO INTERVENTION

SNCU facitities will continue providing routine newborn care services. The staff in the facilities will not be provided training from the intervention.

Interventions

Simulation-based training using Neonatalie PROCEDURE

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.

Also known as: Kangaroo Mother Care, Coaching and Mentoring at hospital, Helping Baby Breathe

SNCUs with Simulation-based Asphyxia Management and Kangaroo Mother Care Training

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Integrated Development Foundation Nepal: lead
• Health Nutrition Education and Agriculture Research Development Nepal: collaborator
• Laerdal Foundation, Norway: collaborator
• Development and Research Service International Nepal: collaborator

Related Publications (9)

• Ministry of Health. Government of Nepal. (2016). Nepal's Every Newborn Action Plan.

  BACKGROUND

• 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.

  PMID: 35012655 BACKGROUND

• 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.

  PMID: 31848924 BACKGROUND

• 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].

  BACKGROUND

• Governement of Nepal. National Planning Commission. (2018). Sustainable Development Goals, Status and Roadmap_ 2016-2030.

  BACKGROUND

• 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.

  PMID: 28573945 BACKGROUND

• 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.

  PMID: 40845050 BACKGROUND

• 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.

  PMID: 35204855 BACKGROUND

• 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.

  PMID: 31906938 BACKGROUND

MeSH Terms

Conditions

Asphyxia Neonatorum

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Khem Narayan Pokhrel, PhD

CONTACT

9779851113827; pokhrelkhemn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Principle investigator along with other investigators will not be participating in radomiziation and allocation. Independent statistician will randomize the clusters and allocate the intervention and control. Allocation will be placed in the concealed invelope to have the name of the cluster for intervention and control arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Lead

Model Details: The intervention is mixed intervention covering training using simulator and coaching and mentoring to newborn care service providers

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: May 2028-July 2028
• Access Criteria: The request should come from formal email.