Saving Little Lives Minimum Care Package Interventions in 290 Public Health Facilities in Ethiopia: Protocol for a Non-Randomized Stepped-Wedge Cluster Implementation Trial

BACKGROUND: Neonatal mortality remains a significant public health challenge in Ethiopia. Despite efforts to implement key evidence-based interventions, their coverage and utilization remain low. The Saving Little Lives (SLL) program aims to scale-up a Minimum Care Package (MCP) of synergistic, life-saving interventions for all liveborn neonates, with a focus on preterm and low birth weight (LBW) infants, across 290 hospitals in Ethiopia (206 primary, 69 general, and 15 referral hospitals), representing 82% of all hospitals in the country at the time of the study, and evaluate the impact on neonatal mortality. METHODS: A non-randomized stepped-wedge trial will be conducted to evaluate the impact of implementing the SLL MCP interventions. Quantitative evaluation data will be collected from 36 primary hospitals, selected from 206 primary hospitals across four regions, receiving the interventions. An independent evaluation research assistant will be deployed in each of the hospitals to collect data using Open Data Kit (ODK) through interviewing mothers before discharge, on the 29th day of life if discharged, and reviewing medical records. A mixed-method, cross-sectional formative assessment will be conducted prior to implementation, employing quantitative facility assessment and qualitative interviews with mothers, healthcare providers, and facility managers. This will be followed by continuous program learning assessment once implementation begins. Descriptive data will be presented using numbers, percentages, tables, and graphs. Regression modeling and generalized estimating equations (GEEs) will be used to estimate the impact of the SLL MCP interventions. Qualitative data will be gathered through in-depth interviews, digitally recorded, transcribed, and thematically analyzed using ATLAS.ti Version 7.5 software to assess facility readiness, barriers, and enablers of implementing the SLL MCP interventions. Expected Outcome: We hypothesize that achieving 80% coverage of the SLL MCP interventions among eligible neonates will result in a 35% reduction in neonatal mortality at implementation facilities.