Oxygen therapy for children with an oxygen saturation of 90–93% in Malawi: the NoGoLO 2 pilot randomised controlled trial
Year: 2026
Type: article
Study design: Clinical Trial
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 (SpO 2 ) <90%. Children in low- and middle-income countries with an SpO 2 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 2 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 2 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 2 <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 2 of 90–93% in Malawi. Trial registration number NCT06176664 .
Source: BMJ Paediatrics Open
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
Funders: National Science and Technology Council, Deanship of Scientific Research, King Khalid University, Foundation for the National Institutes of Health, Mayo Clinic, Alzheimer's Association, Oak Foundation, Ronald McDonald House Charities, Wisconsin Alumni Research Foundation, Thrasher Research Fund, George Mason University, Västra Götalandsregionen, Natural Science Foundation of Jilin Province, Johns Hopkins University, Institut Français de Recherche pour l'Exploitation de la Mer, Norges Teknisk-Naturvitenskapelige Universitet, British Society for Geomorphology, Wellcome Trust, Ögonfonden, Newton Fund, McCusker Charitable Foundation, ACCP Foundation, McJunkin Family Charitable Foundation, ISblue, Centers for Disease Control and Prevention Foundation, National Institute for Health and Care Research, Deutsche Forschungsgemeinschaft, Fundação de Amparo à Pesquisa do Estado de São Paulo, National Natural Science Foundation of China, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior, King Saud University, China Postdoctoral Science Foundation, Natural Science Foundation of Guangdong Province, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Knut och Alice Wallenbergs Stiftelse, Vetenskapsrådet, KWF Kankerbestrijding, Financiadora de Estudos e Projetos, Grand Challenges Canada, Astellas Pharma, Göteborgs Läkaresällskap, China Academy of Chinese Medical Sciences, Forskningsrådet om Hälsa, Arbetsliv och Välfärd, International AIDS Society, Region Skåne, Bracco Diagnostics, Gdański Uniwersytet Medyczny, Department of Science and Technology, Republic of the Philippines, De Blindas Vänner, Sabzevar University of Medical Sciences, Ministry of Science and ICT, South Korea, Korea Ginseng Corporation, Kaohsiung Armed Forces General Hospital, National Science and Technology Major Project, Medical and Health Science and Technology Development Project of Shandong Province, National Institutes of Health, Chief Scientist Office, Scottish Government Health and Social Care Directorate, Emory Global Health Institute, Department of Anesthesiology and Critical Care Medicine, Johns Hopkins Medicine, Canadian Institutes of Health Research, School of Medicine, Shanghai Jiao Tong University, Research for Patient Benefit Programme, Key Technologies Research and Development Program, National Key Research and Development Program of China, West China Hospital, Sichuan University, National Ten Thousand Talent Program, Special Fund Project for Science and Technology Innovation Strategy of Guangdong Province, Project of Qingdao Leading Talents in Entrepreneurship and Innovation, Basic and Applied Basic Research Foundation of Guangdong Province, National Institute on Aging, National Institute of Neurological Disorders and Stroke, Congressionally Directed Medical Research Programs
OpenAlex ID: W7148960958