Research question: In invasively ventilated critically ill children referred as an emergency for paediatric intensive care receiving supplementary oxygen \[Population\] what are the effects of a conservative oxygen therapy \[Intervention\] compared with a liberal oxygen therapy \[Comparator\] on longer-term neurodevelopmental function \[Outcome\]?
Background: We recently completed the NIHR funded Oxy-PICU randomised clinical trial (RCT) which compared conservative versus liberal oxygenation targets in emergency admissions to PICU receiving invasive mechanical ventilation. The results showed a small but significant reduction in the number of days spent receiving organ support or death by day 30 with conservative oxygenation. While the effect size, in terms of the primary outcome, may appear small, if true, these results are clinically important to patients/parents and the NHS. While conservative oxygenation appears effective in the short term, questions still remain about the effects of targeting lower oxygen saturations on longer-term neurodevelopmental function, with calls made from PICU clinicians for this to be investigated prior to wider spread adoption of the Oxy-PICU trial results.
Aim: to extend and undertake additional follow-up of children enrolled in the Oxy-PICU RCT, to determine the effects of conservative oxygen therapy on longer-term neurodevelopmental function in critically ill children.
Methods: 1,112 parents of children included in the Oxy-PICU RCT will be invited by email and post to take part in this longer-term follow-up study. After agreeing to participate, we will arrange a telephone interview with the parent(s) consisting of two validated questionnaires: 1. Vineland Behaviour Scales, third edition (VABS-3) and 2. PedsQL™ 4.0 (Pediatric Quality of Life Inventory) which provide a validated proxy for neurodevelopmental functioning and quality of life, respectively. Once the interview has been completed, we will provide a report to the parents detailing their child's development.
Primary outcome: neurodevelopmental function defined as the overall adaptive behaviour VABS-3 score.
Sample size: Anticipating 50% of those approached agreeing to take part in this study, 556 parents completing telephone interviews will provide enough people to detect a clinically important difference in neurological and developmental function in children treated with conservative oxygen saturations compared with higher oxygen saturations.
Timeline: Total duration: 24 months: months 1-3: HRA approval and interview training; months 4-21: patient/parent recruitment and telephone interviews; months 22-24: analysis and dissemination.
Impact and dissemination: This research will have a large and immediate impact on patients, parents/guardians and the NHS. Understanding the neurodevelopmental effects of conservative oxygen therapy is imperative for implementation of the Oxy-PICU results, which has the potential for important clinical benefit for critically ill children and the NHS. We will actively disseminate the results of the Oxy-PICU neurodevelopmental follow-up study with specific outputs targeted at patients and the public, PICU clinicians/researchers and policy makers. Outputs targeting patients and public will be co-designed with PPI representatives.
