Oxygen therapy for children with an oxygen saturation of 90-93% in Malawi: the NoGoLO₂ pilot randomised controlled trial.

• 72% of eligible children (21 of 29) were enrolled and randomised into the three treatment arms
• Average of 0.8 protocol deviations per participant met the feasibility threshold of ≤2 deviations
• 14.3% of participants (3 of 21) experienced treatment failure within 14 days
• No participants withdrew from the study and all were successfully followed for 14-day outcomes
• Protocol violations were mainly related to medication availability and routine care rather than the study intervention itself

Limitations

This is a pilot feasibility study with only 21 participants, so it cannot determine whether any of the three oxygen therapy approaches is more effective than the others at improving child survival or health outcomes. The open-label design (participants and staff knew which treatment was given) may have influenced treatment and outcome reporting.

Abstract

Objective Oxygen is a cornerstone treatment for pneumonia with hypoxaemia. WHO guidelines recommend oxygen therapy for children with a peripheral arterial haemoglobin oxygen saturation (SpO2) <90%. Children in low- and middle-income countries with an SpO2 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 SpO2 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 SpO2 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 SpO2 <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 SpO2 of 90-93% in Malawi. Trial registration number NCT06176664.