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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 < 5 years hospitalized with hypoxemia (saturation < 92%) warranting hospital admission based on clinical judgement.  Randomization methods:  Random installation order generated  a priori  with allocation concealment.  Study procedure:  Patients receive standard of care within pediatric wards with or without SPO 2  system installed.  Outcome measures:  Primary: 48-h mortality. Secondary: safety, efficacy, SPO 2  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 SPO 2  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 after introduction of SPO 2 , based on a computer simulation of > 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.

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