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

van Miert, Clare, Fernandes, Ricardo M, Eccleson, Helen, Bedson, Emma, Lane, Steven, Peak, Matthew ORCID: 0000-0003-1909-3211, Thorburn, Kent, Compton, Vanessa, Woolfall, Kerry ORCID: 0000-0002-5726-5304, Lacy, David
et al (show 2 more authors) (2018) Non-invasive ventilation for the management of children with bronchiolitis (NOVEMBR): a feasibility study and core outcome set development protocol. TRIALS, 19 (1). 627-.

Access the full-text of this item by clicking on the Open Access link.
[thumbnail of Novembr protocol.pdf] Text
Novembr protocol.pdf - Published version

Download (858kB)


<h4>Background</h4>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.<h4>Methods/design</h4>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.<h4>Discussion</h4>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.<h4>Trial registration</h4>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).

Item Type: Article
Uncontrolled Keywords: Bronchiolitis, High-flow nasal cannula, Nasal continuous positive airway pressure, Oxygen inhalation therapy, Core outcome sets
Depositing User: Symplectic Admin
Date Deposited: 22 Nov 2018 10:09
Last Modified: 19 Jan 2023 01:12
DOI: 10.1186/s13063-018-2969-9
Open Access URL:
Related URLs: