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Original research
High-flow oxygen therapy in moderate to severe bronchiolitis: a randomised controlled trial
  1. Louise Kooiman1,
  2. Fenneke Blankespoor1,
  3. Roy Hofman1,
  4. Arvid Kamps2,
  5. Monique Gorissen3,
  6. Anja Vaessen-Verberne4,
  7. Ingrid Heuts5,
  8. Jolita Bekhof1
  1. 1 Department of Paediatrics, Isala, Zwolle, The Netherlands
  2. 2 Department of Paediatrics, Martini Hospital, Groningen, The Netherlands
  3. 3 Deventer Ziekenhuis, Deventer, The Netherlands
  4. 4 Department of Pediatrics, Amphia Hospital Location Langendijk, Breda, The Netherlands
  5. 5 Department of Paediatrics, Ikazia Hospital, Rotterdam, The Netherlands
  1. Correspondence to Dr Jolita Bekhof, Isala, Zwolle, 8000GK, The Netherlands; j.bekhof{at}isala.nl

Abstract

Background and objective High-flow (HF) oxygen therapy is being used increasingly in infants with bronchiolitis, despite lack of convincing evidence of its superiority over low flow (LF). We aimed to compare the effect of HF to LF in moderate to severe bronchiolitis.

Methods Multicentre randomised controlled trial during four winter seasons (2016–2020) including 107 children under 2 years of age admitted with moderate to severe bronchiolitis, oxygen saturation of <92% and severely impaired vital signs. Crossovers were not allowed. HF was administered at flow rates of 2 L/kg for the first 10 kg, plus 0.5 L/kg for every kg >10 kg, LF with a maximum flow rate of 3 L/min. Primary outcome was improvement of vital signs and dyspnoea severity within 24 hours assessed by a composite score. Secondary outcomes were comfort, duration of oxygen therapy, supplemental feedings, hospitalisation duration and intensive care admission for invasive ventilation.

Results Significant improvement within 24 hours occurred in 73% of 55 patients randomised to HF and in 78% of 52 patients with LF (difference 6%, 95% CI −13% to 23%). Intention-to-treat analysis revealed no significant differences in any secondary outcome: duration of oxygen therapy, supplemental feedings, hospitalisation and need for invasive ventilation or intensive care admission, except for comfort (face, legs, activity, cry, consolability), which was one point (out of a scale of 0–10) higher in the LF group. No adverse effects occurred.

Conclusion We found no measurable clinically relevant benefit in the use of HF compared with LF in hypoxic children with moderate to severe bronchiolitis.

Trial registration number NCT02913040.

  • Paediatrics
  • Respiratory Medicine

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/archdischild-2022-324697

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • Twitter @JolitaBekhof

    • Contributors LK carried out the data collection during the first two winter seasons and the initial analyses, drafted the initial manuscript and approved the final manuscript as submitted. FB performed data collection during the fourth winter season and the final data analysis and drafted several versions of the manuscript. Both FB as JB verified the data. RH performed data collection during the third winter season and performed interim analysis. AK, MG, AV-V and IH contributed to the design of the study and coordinated data collections at the specific study site. JB conceptualised and designed the study, coordinated and supervised the process, critically reviewed the manuscript, wrote the final draft as submitted and is guarantor.

    • Funding Isala’s foundation for Innovation and Research funded this study with a grant of 65.900 € (grant number INNO 1621).

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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