FIRST-line support for Assistance in Breathing in Children (FIRST-ABC)
Research type
Research Study
Full title
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
IRAS ID
260536
Contact name
Padmanabhan Ramnarayan
Contact email
Sponsor organisation
Great Ormond Street Hospital for Children NHS Foundation Trust
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Many of the 20,000 children admitted to NHS paediatric critical care units yearly need support for their breathing. The most invasive form of breathing support is when a child has a tube inserted into their windpipe and is put on a breathing machine. To reduce the number of children needing invasive support, non-invasive methods like Continuous Positive Airway Pressure (CPAP) are used. CPAP provides oxygen/air through a face mask or into the nose. Although CPAP is beneficial, some children find it uncomfortable and some have complications.
A more recent alternative is called High Flow Nasal Cannula (HFNC). HFNC provides oxygen/air through tiny tubes inserted into the nostrils. Less is known about benefits or safety of HFNC, however, hospitals are starting to use HFNC instead of CPAP as it is easier to use and some children appear more comfortable on it. Thus, there is widespread variation across the country in which method is used. Before HFNC is adopted more widely, it is crucial that its role is studied closely.
We will study whether HFNC is as effective as CPAP by doing two randomised clinical trials (RCTs) under one framework (FIRST-ABC). Each RCT will include 600 children, from 25 paediatric critical care units, who require non-invasive breathing support to either help:
1. prevent them from going onto a ventilator (step-up RCT) or
2. prevent them from going back on a ventilator after having just come off one (step-down RCT).Children will be randomly assigned to either CPAP or HFNC as first-line method of non-invasive breathing support. Previously, we tested the trial procedures in a small study and confirmed that it was feasible to do this trial.
FIRST-ABC will provide much needed evidence and will have a large and immediate impact on how sick children are cared for in the NHS.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
19/EE/0185
Date of REC Opinion
26 Jul 2019
REC opinion
Further Information Favourable Opinion