Solar-powered oxygen delivery for the treatment of children with hypoxemia: protocol for a cluster-randomized stepped-wedge controlled trial in Uganda

This study aims to demonstrate the efficacy of SPO2 in children hospitalized with acute hypoxemic respiratory illness across Uganda.MethodsObjectives: Demonstrate efficacy of SPO2 in children hospitalized with acute hypoxemic respiratory illness.Study design: Multi-center, stepped-wedge cluster-randomized trial.Setting: Twenty health facilities across Uganda, a low-income, high-burden country for pediatric pneumonia.Site selection: Facilities with pediatric inpatient services lacking consistent O2 supply on pediatric wards.Participants: Children aged<  5 years hospitalized with hypoxemia (saturation <  92%) warranting hospital admission based on clinical judgement.Randomization methods: Random installation order generateda priori with allocation concealment.Study procedure: Patients receive standard of care within pediatric wards with or without SPO2 system installed.Outcome measures: Primary: 48-h mortality. Secondary: safety, efficacy, SPO2 system functionality, operating costs, nursing knowledge, skills, and retention for oxygen administration.Statistical analysis of primary outcome: Linear mixed effects logistic regression model with 48-h mortality (dependent variable) as a function of SPO2 treatment (before versus after installation), while adjusting for confounding effects of calendar time (fixed effect) and site (random effect).Sample size: 2400 patients across 20 health facilities, predicted to provide 80% power to detect a 35% reduction in mortality aft...
Source: Trials - Category: Research Source Type: clinical trials