Prone versus supine positioning for infants with acute breathing problems
Positioning of Children With Acute Respiratory Insufficiency
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | N/A to 12 Months |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 1 site (Odense) |
| Trial ID | NCT07170085 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Odense
- Hans Christian Andersen´s Childrens Hospital — Odense, Denmark (Recruiting)
Study contacts
- Study coordinator: Josefine Gradman, MD, PhD
- Email: josefine.gradman@rsyd.dk
- Phone: +4529241375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.