Oxy-PICU Neurodevelopmental Follow-up Study

NCT06734715 | Not Yet Recruiting

• 2 other identifiers: Oxy-PICU ND v1.0NIHR206910
• Study Type: observational
• Target: 556
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background to the research: Each year around 20,000 children are admitted to paediatric intensive care units (PICUs) in the UK. Of these children, \~75% will receive support from a breathing machine (or ventilator) in combination with additional oxygen. We recently completed the NIHR funded Oxy-PICU randomised clinical trial (RCT) - a study that compares one treatment against another to determine which is best. The Oxy-PICU RCT investigated whether children in PICU who are receiving help from a ventilator with additional oxygen, should have their oxygen levels kept at a lower level or higher level which currently used in the NHS. We 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 and their 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. Aim of the research: This research aims to complete longer-term follow-up of children included in the Oxy-PICU RCT. We will look at the effect of aiming for lower oxygen levels compared to higher oxygen levels on longer-term developmental milestones. Research plan: We will invite 1,112 parents of children included in the Oxy-PICU RCT by email and post to take part. We will arrange a telephone interview with the parent(s) who agree to participate. A trained researcher will use standard questionnaires to measure important issues. They'll establish if the children are meeting their developmental milestones and learn about their health related quality of life. After the interview we will provide a report to the parents detailing their child's development. We anticipate 50% of those approached will agree to take part in this study. This will allow us to detect important differences in developmental milestones in children treated with lower oxygen levels. Patient and public involvement: PPI has been essential throughout Oxy-PICU. Our PPI co-applicant has been involved in Oxy-PICU from the start as a key member of the study team and will continue to help oversee all aspects of this research. We will also appoint a parent advisory group to provide additional PPI input into the study processes. Knowledge mobilisation: Outputs from the neurodevelopmental follow-up will be specifically targeted to the key stakeholders including patients/parents, clinicians and policy makers. Outputs for patients/parents and the public will be co-produced with our PPI representatives.

Conditions

Intensive Care Pediatric

Keywords

Neurodevelopment; Paediatric critical care; Oxygen

Outcome Measures

Primary Outcomes (1)

• Neurodevelopmental function defined as the overall adaptive behaviour score assessed using the Vineland Adaptive Behaviour Scales, third edition (VABS-3).

  Overall adaptive behaviour score obtained from the Vineland Adaptive Behaviour Scales, third edition (VABS-3) questionnaire.

  4 years post randomization into the Oxy-PICU RCT (ISRCTN92103439)

Secondary Outcomes (2)

• VABS-3 domain scores

  4 years post randomization into the Oxy-PICU RCT (ISRCTN92103439)

• Health related quality of life

  4 years post randomization into the Oxy-PICU RCT (ISRCTN92103439)

Study Arms (2)

Conservative oxygenation

Patients that have previously received treatment in paediatric intensive care with conservative oxygenation

Other: Conservative oxygenation

Liberal oxygenation

Patients that have previously received treatment in paediatric intensive care with liberal oxygenation

Other: Liberal oxygenation

Interventions

Conservative oxygenation OTHER

Patients that were previously randomised to receive conservative oxygenation while in paediatric intensive care

Conservative oxygenation

Liberal oxygenation OTHER

Patients that were previously randomised to receive conservative oxygenation while in paediatric intensive care

Liberal oxygenation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parents/caregivers of children enrolled into Oxy-PICU and who provided consent to be contacted about future related research.

You may qualify if:

• Parent or caregiver of child included in the Oxy-PICU RCT;
• Provided consent to be contacted about future research;
• Living with child; and
• Child/young person survival status confirmed.

You may not qualify if:

• None.

Sponsors & Collaborators

• Intensive Care National Audit & Research Centre: lead
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator

Central Study Contacts

Doug Gould, PhD

CONTACT

+4420 7831 6878; Doug.Gould@icnarc.org

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12