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

• Published in: Current controlled trials in cardiovascular medicine 2018-11, Vol.19 (1), p.627-627, Article 627
• Main Authors: van Miert, Clare, Fernandes, Ricardo M, Eccleson, Helen, Bedson, Emma, Lane, Steven, Peak, Matthew, Thorburn, Kent, Compton, Vanessa, Woolfall, Kerry, Lacy, David, Williamson, Paula, McNamara, Paul S
• Format: Article
• Language: English
• Subjects: Age Factors; Bronchiolitis; Bronchiolitis - diagnosis; Bronchiolitis - physiopathology; Bronchiolitis - therapy; Care and treatment; Caregivers; Child, Preschool; Clinical medicine; Clinical trials; Comparative Effectiveness Research; Consensus; Consent; Continuous positive airway pressure; Continuous Positive Airway Pressure - adverse effects; Continuous Positive Airway Pressure - methods; Core outcome sets; Critical care; Delphi Technique; Demographic aspects; Emergency medical care; Endpoint Determination; Feasibility Studies; Focus Groups; High-flow nasal cannula; Humans; Infant; Infant, Newborn; Intensive care; Interviews as Topic; Lung - physiopathology; Mechanical ventilation; Methods; Multicenter Studies as Topic; Nasal continuous positive airway pressure; Noninvasive Ventilation - adverse effects; Noninvasive Ventilation - methods; Oxygen inhalation therapy; Oxygen Inhalation Therapy - adverse effects; Oxygen Inhalation Therapy - methods; Oxygen therapy; Parents & parenting; Pediatrics; Randomized Controlled Trials as Topic; Research Design; Study Protocol; Systematic Reviews as Topic; Treatment Outcome; United Kingdom; Ventilators
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-018-2969-9

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. 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. 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. 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).