Status: Open to recruitment
What is this study about?
Around 20,000 children are admitted to NHS paediatric critical care units each year. Many of these children need breathing support while in paediatric critical care. The most invasive form of breathing support is when a child has a tube inserted into their windpipe and is put on a ventilator.
To reduce the number of children needing invasive support, non-invasive breathing support methods like Continuous Positive Airway Pressure (CPAP) are used. CPAP provides oxygen or 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 or air through tiny tubes inserted into the nostrils. There is little research on whether HFNC is beneficial or safe. However, many PICUs are starting to use HFNC instead of CPAP as it is easier to use, and children appear more comfortable on it. This means that there is widespread variation across in the country in which methods are used. Before HFNC is adopted more widely, it is crucial that its role is closely studied.
We will study whether HFNC is as effective as CPAP by carrying out two randomised clinical trials (RCTs) under one framework (FIRST-ABC). The RCTs will include 1,200 children (600 in each), from 25 PICUs, 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).
In each RCT, children will be randomly assigned to receive either CPAP or HFNC as the first-line method of non-invasive breathing support.
Click here for information about the FIRST-ABC Pilot Study.
When is it taking place?
The study is due to start patient recruitment in the summer of 2019 and complete in early 2022.
Who is leading the study?
Dr Padmanabhan Ramnarayan, Great Ormond Street Hospital for Children NHS Foundation Trust, London
This study is funded by the National Institute for Health Research (NIHR) – Health Technology Assessment (HTA) Programme (project number: 17/94/28)