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

Alvin Richards-Belle, Peter Davis, Laura Drikite, Richard Feltbower, Richard Grieve, David A. Harrison, Julie Lester, Kevin P. Morris, Paul R. Mouncey, Mark J. Peters, Kathryn M. Rowan, Zia Sadique, Lyvonne N. Tume, Padmanabhan Ramnarayan

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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.

Original languageEnglish
Pages (from-to)e038002
JournalBMJ Open
Volume10
Issue number8
Early online date4 Aug 2020
DOIs
Publication statusPublished - 4 Aug 2020

Keywords

  • clinical trials
  • paediatric intensive & critical care
  • statistics & research methods

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