Abstract
Neonatal mortality remains a major public health concern in Nepal despite progress in maternal and child health. The national neonatal mortality rate is approximately 21 per 1,000 live births, with disproportionately higher burden in Madhesh and Sudurpaschim provinces Birth asphyxia is a leading and largely preventable cause of early neonatal death particularly in public-sector primary health facilities where provider competency, skill retention and resuscitation readiness remain inconsistent. Evidence shows that timely resuscitation within the “Golden Minute” can avert a substantial proportion of these deaths; however, one-time training is insufficient because skills deteriorate without regular practice and supportive supervision.
This study proposes a facility-level cluster randomized controlled trial (cRCT) to evaluate the effectiveness of a comprehensive Helping Babies Breathe (HBB) intervention strengthened through a low-dose high-frequency (LDHF) practice model. The intervention integrates structured HBB refresher training, monthly short LDHF drills coordinated by a designated facility HBB focal person, provision and maintenance of essential resuscitation equipment, quarterly supportive supervision and mentorship, use of practice logbooks and strengthening of referral systems. Control facilities will continue standard maternity and newborn care in accordance with Ministry of Health and Population guidelines.
The study will be conducted in four purposively selected high-burden districts: Dhanusha and Mahottari in Madhesh Province, and Kailali and Kanchanpur in Sudurpaschim Province. A total of 52 public-sector delivery facilities will be included as clusters, with district-level allocation yielding 26 intervention and 26 control facilities. All deliveries occurring in the selected facilities during the 12 month study period will be consecutively recorded to measure neonatal outcomes.
Primary outcomes are facility-based neonatal mortality and fresh stillbirth rates. Secondary outcomes include provider competency (knowledge and OSCE scores), facility readiness for neonatal resuscitation, availability and functionality of essential equipment, fidelity of LDHF practice, referral system and effectiveness of the intervention. Quantitative data will be collected prospectively from delivery and newborn registers, standardized facility readiness checklists and structured provider assessments at baseline and end line. LDHF practice will be monitored through routine logbooks verified during supportive supervision visits. Qualitative implementation insights will be documented through supervision reports.
Data will be analyzed using an intention-to-treat approach with cluster-adjusted statistical methods to account for facility-level randomization. Pre- and post-intervention comparisons will assess changes in provider competency and facility readiness. An incremental cost-effectiveness analysis will estimate the cost per neonatal life saved, and thematic analysis of implementation data will inform feasibility and scalability.
This study is expected to generate robust, policy-relevant evidence on whether a systems oriented HBB low dose high frequency training can reduce preventable neonatal deaths in health care. Findings will inform national scale-up strategies, integration of routine practice-based resuscitation training into maternal and newborn programs.