Intensive Care PediatricOxy-PICU NDNCT06734715
Oxy-PICU Neurodevelopmental Follow-up Study
An observational study of Intensive Care Pediatric, run by Intensive Care National Audit & Research Centre.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intensive Care Pediatric
- What is being tested?
- Conservative oxygenation and Liberal oxygenation
- How many people
- 556 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Parents/caregivers of children enrolled into Oxy-PICU and who provided consent to be contacted about future related research.
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Intensive Care Pediatric
- Being tested
- Conservative oxygenation, Liberal oxygenation
- Keywords
- Neurodevelopment, Paediatric critical care, Oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative oxygenationOther
Patients that were previously randomised to receive conservative oxygenation while in paediatric intensive care
Liberal oxygenationOther
Patients that were previously randomised to receive conservative oxygenation while in paediatric intensive care
| Study group | Role | What they receive |
|---|---|---|
| Conservative oxygenation | Patients that have previously received treatment in paediatric intensive care with conservative oxygenation Receives: Other: Conservative oxygenation | |
| Liberal oxygenation | Patients that have previously received treatment in paediatric intensive care with liberal oxygenation Receives: Other: Liberal oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years post randomization into the Oxy-PICU RCT (ISRCTN92103439)
Secondary outcomes (2)
VABS-3 domain scores
Individual VABS-3 domain scores (communication, daily living skills, socialisation, motor skills in younger children)
Measured: 4 years post randomization into the Oxy-PICU RCT (ISRCTN92103439)
Health related quality of life
Health related quality of life (HRQoL) measured using the Pediatric Quality of Life Inventory (PedsQL™) 4.0.
Measured: 4 years post randomization into the Oxy-PICU RCT (ISRCTN92103439)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care PediatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 556 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intensive Care National Audit & Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734715
- Sponsor's protocol ID
- Oxy-PICU ND v1.0
- Other IDs
- NIHR206910
- Acronym
- Oxy-PICU ND
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxy-PICU Neurodevelopmental Follow-up Study
- ClinicalTrials.gov ID
- NCT06734715
- Acronym / sponsor ID
- Oxy-PICU ND / Oxy-PICU ND v1.0
- Conditions
- Intensive Care Pediatric
- Keywords
- Neurodevelopment, Paediatric critical care, Oxygen
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- Intensive Care National Audit & Research CentreUniversity, hospital or other
- Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative oxygenation | – | Other: Conservative oxygenationPatients that have previously received treatment in paediatric intensive care with conservative oxygenation |
| Liberal oxygenation | – | Other: Liberal oxygenationPatients that have previously received treatment in paediatric intensive care with liberal oxygenation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parents/caregivers of children enrolled into Oxy-PICU and who provided consent to be contacted about future related research.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative oxygenationPatients that were previously randomised to receive conservative oxygenation while in paediatric intensive care | Other | Conservative oxygenation |
| Liberal oxygenationPatients that were previously randomised to receive conservative oxygenation while in paediatric intensive care | Other | Liberal oxygenation |
Primary outcome
Neurodevelopmental function defined as the overall adaptive behaviour score assessed using the Vineland Adaptive Behaviour Scales, third edition (VABS-3).
Time frame: 4 years post randomization into the Oxy-PICU RCT (ISRCTN92103439)
Overall adaptive behaviour score obtained from the Vineland Adaptive Behaviour Scales, third edition (VABS-3) questionnaire.
2 secondary outcomes
VABS-3 domain scores
Time frame: 4 years post randomization into the Oxy-PICU RCT (ISRCTN92103439)
Health related quality of life
Time frame: 4 years post randomization into the Oxy-PICU RCT (ISRCTN92103439)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Pediatric, run by Intensive Care National Audit & Research Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doug Gould, PhD (+4420 7831 6878, Doug.Gould@icnarc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurodevelopmental function defined as the overall adaptive behaviour score assessed using the Vineland Adaptive Behaviour Scales, third edition (VABS-3). (time frame: 4 years post randomization into the Oxy-PICU RCT (ISRCTN92103439)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.