{
  "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 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 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.",
  "authors": [
    {
      "affiliations": [
        "Department of Anesthesia and Critical Care Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA",
        "Global Program in Pediatric Respiratory Sciences, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA"
      ],
      "name": "Kristen S Joseph"
    },
    {
      "affiliations": [
        "University of North Carolina Project Malawi, Lilongwe, Malawi",
        "Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA"
      ],
      "name": "Tisungane Mvalo"
    },
    {
      "affiliations": [
        "Department of Anesthesia and Critical Care Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA"
      ],
      "name": "Nicole Shilkofski"
    },
    {
      "affiliations": [
        "Institute for Global Health, University College London, London, UK"
      ],
      "name": "Tim Colbourn"
    },
    {
      "affiliations": [
        "Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA"
      ],
      "name": "Holly Schuh"
    },
    {
      "affiliations": [
        "Department of Paediatrics and Child Health, Desmond Tutu TB Centre, Stellenbosch University, Cape Town, South Africa"
      ],
      "name": "Marieke M van der Zalm"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Child & Youth Health, The University of Auckland, Auckland, New Zealand",
        "College of Medicine, Nursing and Health Sciences, Fiji National University, Suva, Fiji"
      ],
      "name": "Stephen Howie"
    },
    {
      "affiliations": [
        "Department of Global Public Health, Karolinska Institutet, Solna, Sweden"
      ],
      "name": "Carina King"
    },
    {
      "affiliations": [
        "Global Program in Pediatric Respiratory Sciences, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA",
        "Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA"
      ],
      "name": "Eric D McCollum"
    }
  ],
  "title": "Oxygen therapy for children with an oxygen saturation of 90–93% in Malawi: the NoGoLO2 pilot randomised controlled trial",
  "uid": "7e6744d2-b859-5da2-811f-2f0af18a04f3"
}