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. Issue 8 (4th August 2020)

• Record Type: Journal Article
• Authors: Richards-Belle, Alvin; Davis, Peter; Drikite, Laura; Feltbower, Richard; Grieve, Richard; Harrison, David A; Lester, Julie; Morris, Kevin P; Mouncey, Paul R; Peters, Mark J; Rowan, Kathryn M; Sadique, Zia; Tume, Lyvonne N; Ramnarayan, Padmanabhan
• Is Part Of: BMJ open. Volume 10:Issue 8(2020)
• Publication Date: 2020-08-04
• Subjects: paediatric intensive & critical care -- paediatric intensive & critical care -- paediatric intensive & critical care -- clinical trials -- statistics & research methods; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-038002
• Languages: English
• ISSNs: 2044-6055

Abstract

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-line support for assistance in breathing in children is a master protocol of two pragmatic non-inferiority RCTs to evaluate the clinical and cost-effectiveness of HFNC (compared with 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 NRS 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 prespecified non-inferiority margin of HR 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 National Health Service 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 number: ISRCTN60048867