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

Abstract

BackgroundBronchiolitis 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/designThis 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.DiscussionThis 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 registrationISRCTN 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).Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2969-9) contains supplementary material, which is available to authorized users.

Which outcomes should be used in future bronchiolitis trials? Developing a bronchiolitis core outcome set using a systematic review, Delphi survey and a consensus workshop

“…This study formed part of a larger research project (Non-Invasive Ventilation for the Management of Children with Bronchiolitis: a feasibility study (NOVEMBR)). 23…”

“…The study protocol was registered retrospectively with the COMET initiative and is available online, 23 and on the ISRCTN Registry (18 December 2017).…”

“…The aim of this study was to obtain consensus from key stakeholders on which outcomes should be included in a COS for use in future bronchiolitis trials and other studies. This study formed part of a larger research project (Non-Invasive Ventilation for the Management of Children with Bronchiolitis: a feasibility study (NOVEMBR)) 23…”

Update on current views and advances on RSV infection (Review)

“…Over the last decade, high-flow nasal cannula (HFNC) therapy has emerged as a new method to provide respiratory support in children with RSV-positive bronchiolitis (12,(123)(124)(125)(126). Its main advantages include its ease to set up and the fact that it is well tolerated, leading to better compliance, especially in comparison to other devices of non-invasive ventilation (125,127).…”

National survey of feasibility of NIV trials for management of children with bronchiolitis

“…This study formed part of a larger research project (Non-Invasive Ventilation for the Management of Children with Bronchiolitis: a feasibility study (NOVEMBR)). 8 …”