FIRST-line support for assistance in breathing in children (FIRST-ABC) : a master protocol of two randomised trials to evaluate the non-inferiority of high flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in paediatric critical care

Richards-Belle, A ORCID: https://orcid.org/0000-0002-2547-8209, Davis, P, Drikite, L, Feltbower, R, Grieve, R, Harrison, D, Lester, J, Morris, K, Mouncey, P, Peters, M, Rowan, K, Sadique, M, Tume, LN ORCID: https://orcid.org/0000-0002-2547-8209 and Padmanabhan, R 2020, 'FIRST-line support for assistance in breathing in children (FIRST-ABC) : a master protocol of two randomised trials to evaluate the non-inferiority of high flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in paediatric critical care' , BMJ Open, 10 , e038002.

[img]
Preview
PDF - Published Version
Available under License Creative Commons Attribution 4.0.

Download (1MB) | Preview
[img] PDF - Accepted Version
Restricted to Repository staff only

Download (313kB)
[img] Microsoft Word - Accepted Version
Restricted to Repository staff only

Download (261kB)

Abstract

Introduction Even though respiratory support is a common intervention in paediatric critical care, there is no randomised controlled trial (RCT) evidence regarding the effectiveness of two commonly used modes of non-invasive respiratory support (NRS), continuous positive airway pressure (CPAP) and high-flow nasal cannula therapy (HFNC). FIRST-ABC is a master protocol of two pragmatic non-inferiority RCTs to evaluate the clinical and cost-effectiveness of HFNC (compared to CPAP) as the first-line mode of support in critically ill children. Methods and analysis We will recruit participants over a 30-month period at 25 UK paediatric critical care units (paediatric intensive care units/high dependency units). Patients are eligible if admitted/accepted for admission, aged >36 weeks corrected gestational age and <16 years, and assessed by the treating clinician to require non-invasive respiratory support for an acute illness (step-up RCT) or within 72 hours of extubation following a period of invasive ventilation (step-down RCT). Due to the emergency nature of the treatment, written informed consent will be deferred to after randomisation. Randomisation will occur 1:1 to CPAP or HFNC, stratified by site and age (<12 vs. ≥12 months). The primary outcome is time to liberation from respiratory support for a continuous period of 48 hours. A total sample size of 600 patients in each RCT will provide 90% power with a type I error rate of 2.5% (one-sided) to exclude the pre-specified noninferiority margin of hazard ratio of 0.75. Primary analyses will be undertaken separately in each RCT in both the intention-to-treat and per-protocol populations. Ethics and dissemination This master protocol received favourable ethical opinion from NHS East of England - Cambridge South Research Ethics Committee (reference: 19/EE/0185) and approval from the Health Research Authority (reference: 260536). Results will be disseminated via publications in peer reviewed medical journals and presentations at national and international conferences. Trial registration ISRCTN60048867; Pre-results.

Item Type: Article
Schools: Schools > School of Health and Society > Centre for Health Sciences Research
Journal or Publication Title: BMJ Open
Publisher: BMJ Publishing Group
ISSN: 2044-6055
Related URLs:
Funders: NIHR HTA
Depositing User: Dr Lyvonne Tume
Date Deposited: 26 Jun 2020 08:46
Last Modified: 05 Aug 2020 14:45
URI: http://usir.salford.ac.uk/id/eprint/57461

Actions (login required)

Edit record (repository staff only) Edit record (repository staff only)

Downloads

Downloads per month over past year