Prone versus supine positioning for infants with acute breathing problems
Official title: Positioning of Children With Acute Respiratory Insufficiency
Run by Odense University Hospital · NCT07170085 · Data updated 2026-11-12
This will test whether placing infants under 1 year who are on CPAP or high-flow oxygen on their stomach (prone) instead of their back (supine) improves their breathing.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 12 Months |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 1 site (Odense) |
| Status | Recruiting |
| Started | November 24, 2025 |
| Main results expected | April 1, 2027 |
| Study ends | April 1, 2028 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT07170085 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants aged 0–12 months hospitalized for infection-related acute respiratory insufficiency who have been started on CPAP or high-flow oxygen and whose legal guardian provides consent.
✕Probably not a fit
Children with significant chronic pulmonary, cardiac, or neurological disorders or those already admitted to intensive care are excluded and may not benefit from the findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an open-label, randomized crossover study enrolling 40 infants under 12 months hospitalized with infection-triggered acute respiratory insufficiency who require CPAP or high-flow oxygen. Each child will spend one hour in the prone position and one hour in the supine position while receiving respiratory support, with the order randomized. Respiratory rate and a symptom score will be recorded to compare respiratory function between positions. The trial is conducted at Hans Christian Andersen's Children's Hospital, Odense University Hospital.
Why it matters
Potential benefit: If successful, positioning infants prone could improve oxygenation and breathing and potentially reduce the need for more invasive respiratory support.
How similar studies have gone: Prone positioning has improved oxygenation in adults with acute respiratory failure, but randomized data specifically in infants on CPAP or high-flow oxygen are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 0-12 months * Clinical respiratory infection * Physician-ordered High-Flow oxygen or CPAP * Consent from the legal guardian Exclusion Criteria: * Significant chronic pulmonary, cardiac, or neurological disorders * Children admitted to intensive care
Where it's running
-
Hans Christian Andersen´s Childrens Hospital
Odense, Denmark Recruiting
Study contacts
- Study coordinator: Josefine Gradman, MD, PhD
- Email: josefine.gradman@rsyd.dk
- Phone: +4529241375
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.