Comparing two levels of CPAP for preterm infants in the delivery room
Pressure HIgh or LOw DElivered to Preterm Newborns in the Delivery ROOM
This study is testing whether using a lower or higher level of breathing support helps preterm babies with breathing problems right after birth breathe better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 26 Weeks to 30 Weeks |
| Sex | All |
| Sponsor | ASST Fatebenefratelli Sacco Academic / other |
| Locations | 1 site (Milano, Lombardy) |
| Trial ID | NCT06123845 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial investigates the effects of two different levels of continuous positive airway pressure (CPAP) on preterm infants with respiratory distress syndrome (RDS) at birth. The study compares the efficacy and safety of administering CPAP at 5 cmH2O versus 8 cmH2O during the first 15 minutes of life to determine which level better promotes lung recruitment. The trial aims to assess short-term respiratory outcomes and the potential long-term benefits of improved lung function in these vulnerable infants. Participants will include preterm infants born between 26 and 29+6 weeks gestational age requiring noninvasive respiratory support.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born between 26 and 29+6 weeks gestational age who require noninvasive respiratory support for RDS.
Not a fit: Patients with congenital anomalies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved respiratory outcomes and reduced complications for preterm infants with RDS.
How similar studies have performed: While various approaches to respiratory support in preterm infants have been studied, this specific comparison of CPAP levels is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preterm infants at birth between 26 and 29+6 weeks gestational age with Respiratory distress syndrome requiring non invasive respiratory support Exclusion Criteria: * Congenital anomalies
Where this trial is running
Milano, Lombardy
- Ospedale dei Bambini Vittore Buzzi — Milano, Lombardy, Italy (Recruiting)
Study contacts
- Study coordinator: Francesco Cavigioli, MD
- Email: francesco.cavigioli@asst-fbf-sacco.it
- Phone: +39263635341
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.