Project Details

Oxygen Therapy for Children with Moderate Hypoxemia in Malawi: Pilot Randomized Control Trial

Kristen Joseph, MD

Summary

Objective: Oxygen is a cornerstone treatment for pneumonia with hypoxemia. World Health Organization (WHO) guidelines recommend oxygen therapy for children with a peripheral arterial hemoglobin saturation (SpO2) < 90%. Children in low- and middle-income countries with a SpO2 90–93% are at increased risk of mortality and may benefit from oxygen therapy. We aimed to determine the feasibility of a randomized controlled trial comparing standard of care (no oxygen), low-flow nasal cannula (LFNC) and high flow nasal cannula (HFNC) among children with pneumonia and a SpO2 90–93%. Design: Pilot, open-label, three-armed randomized control trial (NCT06176664). Setting: Salima District Hospital, Malawi. Patients: Children 1–59 months old with WHO-defined pneumonia and a SpO2 90–93%. Interventions: Standard care (no oxygen), LFNC, or HFNC Main Outcome Measures: The primary outcome was feasibility defined as an average of ≤ 2 protocol deviations per participant. Secondary outcomes included consent refusal, participant attrition, and treatment failure within 14 days. Results: Of the 29 eligible patients, 21 (72%) were enrolled and randomized. There was an average of 0.8 (16/21) deviations per participant. Seven (43.8%) protocol violations were related to study intervention protocols and 9 (56.3%) to medication availability and routine care. No participants withdrew from the study. Three of 21 participants (14.3%) had treatment failure. All participants were successfully followed to obtain the 14-day outcome. Conclusions: A three-armed, open-label randomized control trial is feasible to compare standard of care, LFNC, and HFNC oxygen for children with pneumonia and a SpO2 90–93% in Malawi.