Pilot RCT finds oxygen therapy trial feasible for children with pneumonia and hypoxaemia in Malawi

OBJECTIVE: Oxygen is a cornerstone treatment for pneumonia with hypoxaemia. WHO guidelines recommend oxygen therapy for children with a peripheral arterial haemoglobin oxygen saturation (SpO) <90%. Children in low- and middle-income countries with an SpO of 90-93% are at increased risk of mortality and may benefit from oxygen therapy. We aimed to determine the feasibility of a randomised controlled trial comparing standard of care (no oxygen), low-flow nasal cannula (LFNC) and high-flow nasal cannula (HFNC) among children with pneumonia and an SpO of 90-93%. DESIGN: Pilot, open-label, three-armed randomised control trial (NCT06176664). SETTING: Salima District Hospital, Malawi. PATIENTS: Children 1-59 months old with WHO-defined pneumonia and an SpO of 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. Treatment failure was defined as an SpO <90% for standard care participants or <94% in the LFNC and HFNC arms despite maximum therapy as described, any new severe respiratory distress (grunting, very severe chest indrawing) or any new WHO-defined emergency sign. RESULTS: Of the 29 eligible patients, 21 (72%) were enrolled and randomised. There was an average of 0.8 (16/21) deviations per participant. Seven (43.8%) protocol violations were related to study intervention protocols and nine (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 randomised control trial is feasible to compare standard of care, LFNC and HFNC oxygen for children with pneumonia and an SpO of 90-93% in Malawi. TRIAL REGISTRATION NUMBER: NCT06176664.