Oxygen therapy for children with an oxygen saturation of 90–93% in Malawi: the NoGoLO ₂ pilot randomised controlled trial

OBJECTIVE: of 90-93%. DESIGN: Pilot, open-label, three-armed randomised control trial (NCT06176664). SETTING: Salima District Hospital, Malawi. PATIENTS: of 90-93%. INTERVENTIONS: Standard care (no oxygen), LFNC or HFNC. MAIN OUTCOME MEASURES: <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: of 90-93% in Malawi. TRIAL REGISTRATION NUMBER: NCT06176664.