Comparing two levels of CPAP for preterm infants in the delivery room
Official title: Pressure HIgh or LOw DElivered to Preterm Newborns in the Delivery ROOM
Run by ASST Fatebenefratelli Sacco · NCT06123845 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
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
| Study type | Interventional |
|---|---|
| Ages | 26 Weeks to 30 Weeks |
| Sex | All |
| Enrollment | 56 (estimated) |
| Sponsor | ASST Fatebenefratelli Sacco Academic / other |
| Locations | 1 site (Milano, Lombardy) |
| Trial ID | NCT06123845 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with congenital anomalies will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Surfactant delivery methods in preterm infants with RDS in Sweden
This study tests different ways of giving surfactant to preterm babies with respiratory distress to see which method works best when care is routine.
-
Lung ultrasound score to guide surfactant timing in preterm newborns
This study tests whether using a lung ultrasound score can speed up diagnosing severe RDS and getting surfactant to moderately and late-preterm babies in the NICU.
-
Predicting which newborns in a lower-level NICU will need extended breathing support
This project will test whether analyzing a newborn's stomach fluid right after birth can help predict which babies born at 32+ weeks and attended by the neonatal resuscitation team will need breathing support for more than six hours.
-
Optimising breathing support at extubation for very preterm infants
This trial will try starting nasal CPAP before removing the breathing tube versus starting it after extubation to see if that reduces oxygen drops in very preterm infants.
-
Surfactant given through a laryngeal mask for preterm babies with RDS in Vietnam
For preterm babies under 34 weeks with respiratory distress, the team will try giving surfactant through a soft throat mask (SALSA) instead of an endotracheal tube (INSURE) to see if it reduces the need for invasive breathing support.
-
Giving surfactant to premature infants using a thin catheter at birth
This study is testing if giving a special lung treatment to very premature babies right after birth using a thin tube can help them breathe better and need less breathing support in their first few days of life.
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.