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

Clinical Snapshot

Key Findings

• P Value: Not reported

• Effect Size: Not applicable - feasibility study

• Primary Outcome: Feasibility achieved with 0.8 protocol deviations per participant (target ≤2)

• Nnt Or Sensitivity: Treatment failure rate: 14.3% (3/21 participants)

• Confidence Interval: Not reported

Clinical Application

Demonstrates feasibility for larger definitive trial; oxygen delivery systems appear implementable in district hospital setting Limited direct applicability to Australian practice where oxygen therapy protocols and resources differ significantly; may inform humanitarian or international development work Children 1-59 months with pneumonia and borderline hypoxaemia (SpO2 90-93%) in resource-limited settings

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.

References

1. 1.Joseph, K. S., Mvalo, T., Shilkofski, N., Colbourn, T., Schuh, H., van der Zalm, M. M., Howie, S., King, C., & McCollum, E. D. (2026). Oxygen therapy for children with an oxygen saturation of 90-93% in Malawi: the NoGoLO2 pilot randomised controlled trial. BMJ Paediatrics Open. https://doi.org/10.1136/bmjpo-2025-004256