Lung recruitment maneuvers for preterm infants on high frequency ventilation
Open Lung Maneuvers During High Frequency Oscillatory Ventilation in Extremely Preterm Infants - A Single Center Randomized Controlled Trial
This study is testing if a special way of helping the lungs work better can lower oxygen needs in extremely premature babies on a specific type of breathing machine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | N/A to 8 Weeks |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna, State of Vienna) |
| Trial ID | NCT04289324 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of stepwise oxygenation-guided lung recruitment maneuvers in extremely preterm infants receiving high frequency oscillatory ventilation (HFOV). The aim is to determine if these maneuvers can reduce the oxygen saturation index (OSI) over time compared to standard care. The study involves a single center randomized controlled design with 36 infants below 28 weeks of gestational age. Participants will be divided into two groups: one receiving regular lung recruitment maneuvers and the other receiving them only at the discretion of the care team. The primary outcome will be the average OSI during HFOV.
Who should consider this trial
Good fit: Ideal candidates are extremely preterm infants born below 28 weeks of gestational age who are currently receiving high frequency oscillatory ventilation.
Not a fit: Patients with known congenital anomalies of the heart, lung, or central nervous system, or those with chromosomal abnormalities will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve oxygenation and lung function in extremely preterm infants, potentially reducing complications associated with lung injury.
How similar studies have performed: While the approach of using lung recruitment maneuvers is established, this specific application in extremely preterm infants during HFOV is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Preterm infants * born below 28 weeks of gestational age * not older than 29 weeks of postmenstrual age * receive HFOV Exclusion Criteria: * known congenital anomalies of the heart, of the lung, and/or of the central nervous system * known chromosomal abnormalities * participation in other intervention trials
Where this trial is running
Vienna, State of Vienna
- Medical University of Vienna — Vienna, State of Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Tobias Werther — Medical University of Vienna
- Study coordinator: Tobias Werther
- Email: tobias.werther@meduniwien.ac.at
- Phone: +4314040032320
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.