Oxy-PICU neurodevelopmental (ND) follow-up study
Research type
Research Study
Full title
Assessment of neurodevelopmental function in critically ill children enrolled in the Oxy-PICU trial.
IRAS ID
349416
Contact name
Doug Gould
Contact email
Sponsor organisation
Intensive Care National Audit and Research Centre
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
The recently completed NIHR funded Oxy-PICU randomised clinical trial (RCT) investigated whether children in PICU receiving help from a ventilator with additional oxygen, should have their oxygen levels kept at a lower level or a higher level which is currently used in the NHS. The Oxy-PICU RCT found that aiming for lower oxygen levels was better and resulted in a small but significant reduction in the number of days children spent on machines or died at 30 days. While small, this result would have a large and important impact for patients/families and may have important cost savings for the NHS.
However, while in the short-term targeting lower oxygen levels appears better, the effects on children’s longer-term development are unknown. Knowing this is important to fully inform doctors and nurses about the effects of aiming for lower oxygen levels, and help the results of Oxy-PICU be applied throughout the NHS.
This research will complete longer-term follow-up of children included in the Oxy-PICU RCT to look at the effect of aiming for lower oxygen levels compared to higher oxygen levels on longer-term developmental function. 1,112 parents of children included in OXY-PICU RCT will be invited to participate. After agreeing to participate, parents will take part in an interview by a trained assessor. The interviews will consist of two validated parent-reported questionnaires (VABS-3 and PedsQL 4.0), alongside bespoke questions relating to education, major health events and associated health services usage. This assessment will measure developmental function and health related quality of life. Following the interview, a report will be given to the parent detailing their child’s development.
We aim to recruit 556 participants which will allow us to detect important differences in developmental function in children treated with lower oxygen levels compared with higher oxygen levels.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
25/SC/0016
Date of REC Opinion
3 Mar 2025
REC opinion
Further Information Favourable Opinion