Status: Funded - Open
Kristen Joseph, MD
BACKGROUND: Pneumonia is the leading cause of under-5-year-old mortality worldwide and hypoxemia is a risk factor for mortality. Current guidelines recommend oxygen administration for children with oxygen saturation (SpO2) <90%; however, recent evidence suggests that children with SpO2 90-93% are at increased risk of mortality. GAP: Currently, no randomized trials have determined whether low flow oxygen or high flow nasal canula (HFNC) oxygen treatment reduces the mortality of children with moderate hypoxemia (SpO2 90-93%) in African low- and middle-income countries. HYPOTHESIS: We hypothesize it will be feasible to recruit, randomize, treat, and safely follow-up all participants enrolled in a pilot open-label, parallel randomized controlled trial (RCT) which randomizes children 1-59 months of age with clinical pneumonia and moderate hypoxemia (SpO2 90-93%) to receive standard of care (no oxygen therapy), low flow oxygen, or HFNC oxygen. METHODS: The pilot RCT involves an unblinded, randomized three-arm trial in children 1-59 months of age from Salima, Malawi comparing low-flow and HFNC oxygen to WHO-recommended standard of care without oxygen therapy for WHO-defined pneumonia with moderate hypoxemia (SpO2 90-93%). We plan to evaluate for the overall feasibility of recruitment and study procedures. RESULTS: Pending. IMPACT: Data from this pilot RCT will inform study protocols and procedures for a larger RCT powered for mortality. Understanding if children with moderate hypoxemia benefit from oxygen therapy will inform WHO pneumonia treatment guidelines and may improve under-5-year old mortality.