Trials (Dec 2019)

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

  • Nicholas Conradi,
  • Qaasim Mian,
  • Sophie Namasopo,
  • Andrea L. Conroy,
  • Laura L. Hermann,
  • Charles Olaro,
  • Jackson Amone,
  • Robert O. Opoka,
  • Michael T. Hawkes

DOI
https://doi.org/10.1186/s13063-019-3752-2
Journal volume & issue
Vol. 20, no. 1
pp. 1 – 10

Abstract

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Abstract 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 (SPO2) delivery can reliably provide medical oxygen remote settings with minimal access to electricity. This study aims to demonstrate the efficacy of SPO2 in children hospitalized with acute hypoxemic respiratory illness across Uganda. Methods Objectives: 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 5000 trials. Discussion Overall, our study aims to demonstrate mortality benefit of SPO2 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, SPO2 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.

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