标题:Solar-powered oxygen delivery for the treatment of children with hypoxemia: protocol for a cluster-randomized stepped-wedge controlled trial in Uganda
摘要:BACKGROUND :Child mortality due to pneumonia is a major global health problem and is associated with hypoxemia. Access to safe and continuous oxygen therapy can reduce mortality; however, low-income countries may lack the necessary resources for oxygen delivery. We have previously demonstrated proof-of-concept that solar-powered oxygen (SPO 2 ) delivery can reliably provide medical oxygen remote settings with minimal access to electricity. This study aims to demonstrate the efficacy of SPO 2 in children hospitalized with acute hypoxemic respiratory illness across Uganda. METHODS :Objectives: Demonstrate efficacy of SPO 2 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 O 2 supply on pediatric wards. PARTICIPANTS :Children aged 5000 trials. DISCUSSION :Overall, our study aims to demonstrate mortality benefit of SPO 2 relative to standard (unreliable) oxygen delivery. The innovative trial design (stepped-wedge, cluster-randomized) is supported by a computer simulation. Capacity building for nursing care and oxygen therapy is a non-scientific objective of the study. If successful, SPO 2 could be scaled across a variety of resource-constrained remote or rural settings in sub-Saharan Africa and beyond. TRIAL REGISTRATION :Clinicaltrials.gov, NCT03851783. Registered on 22 February 2019.