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. 2018 Nov 14;19(1):627.
doi: 10.1186/s13063-018-2969-9.

Non-invasive ventilation for the management of children with bronchiolitis (NOVEMBR): a feasibility study and core outcome set development protocol

Clare van Miert  1   2 , Ricardo M Fernandes  3   4 , Helen Eccleson  5 , Emma Bedson  5 , Steven Lane  6 , Matthew Peak  7 , Kent Thorburn  8 , Vanessa Compton  8 , Kerry Woolfall  9 , David Lacy  10 , Paula Williamson  6 , Paul S McNamara  11
Affiliations

Non-invasive ventilation for the management of children with bronchiolitis (NOVEMBR): a feasibility study and core outcome set development protocol

Clare van Miert et al. Trials. .

Abstract

Background: Bronchiolitis is an acute lower respiratory infection which predominantly affects young children. Treatment for bronchiolitis is limited to supportive therapy. Nasal oxygen therapy is part of routine care, and delivery now incorporates varying levels of non-invasive continuous positive airway pressure and/or high-flow nasal cannula oxygen therapy. Despite wide clinical use, there remains a lack of evidence on the comparative effectiveness and safety of these interventions. Furthermore, research in this field is hampered by the use of multiple outcome measures in current clinical trials.

Methods/design: This mixed methods study includes a systematic review of outcome measures, telephone interviews with parents, focus group workshops and a Delphi survey with healthcare professionals and parents. These methods will be used to identify and prioritise outcomes for inclusion in a core outcome set and to explore issues pertinent to the design of a future randomised controlled trial comparing different modes of oxygen therapy for bronchiolitis. UK hospitals will also be contacted and asked to complete a survey to provide an overview of current practice to enable assessment of capability and capacity to run a future clinical trial.

Discussion: This study will facilitate the design of a future clinical trial of non-invasive ventilation in children with bronchiolitis which is acceptable to important stakeholders. Furthermore, core outcome set development will improve standardisation, measurement and reporting of clinically important outcomes in bronchiolitis.

Trial registration: ISRCTN Registry, ISRCTN75766048. Registered on 18 December 2017. This study was retrospectively registered in the ISRCTN Registry and on the Core Outcome Measures in Effectiveness Trials (COMET) Initiative database (15 September 2017).

Keywords: Bronchiolitis; Core outcome sets; High-flow nasal cannula; Nasal continuous positive airway pressure; Oxygen inhalation therapy.

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Conflict of interest statement

Ethics approval and consent to participate

Ethical approval for this protocol was obtained from NHS Health Research Authority, Yorkshire and The Humber - South Yorkshire Research Ethics Committee (REC), REC reference 16/YH/0012; IRAS reference 191271.

Consent for publication

Not applicable.

Competing interests

CvM was an invited speaker at a meeting sponsored by Fisher & Paykel.

PMc sits on an independent data monitoring and safety committee of an early phase trial of an antiviral treatment for bronchiolitis funded by Pulmocide and as an advisor for antiviral trials for bronchiolitis funded by Janssen and Alios.

RF has served on independent data monitoring and safety committees of early phase trials in bronchiolitis funded by Ablynx and on a clinical endpoint committee for an RSV vaccine trial funded by Janssen.

The remaining authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
NOVEMBR study flow diagram
See this image and copyright information in PMC

References

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