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(8): e038002, 2020 08 04.
Article
en En
| MEDLINE
| ID: mdl-32753452
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 ANDANALYSIS:
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 11 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.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Presión de las Vías Aéreas Positiva Contínua
/
Cánula
Tipo de estudio:
Clinical_trials
/
Guideline
Límite:
Aged
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Child
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Humans
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Infant
País/Región como asunto:
Europa
Idioma:
En
Revista:
BMJ Open
Año:
2020
Tipo del documento:
Article
País de afiliación:
Reino Unido