Clinical trial No longer in our active list Interventional Ages 26 Weeks to 30 Weeks

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.

More Respiratory Distress Syndrome in Premature Infant trials

Quick facts

Study typeInterventional
Ages26 Weeks to 30 Weeks
SexAll
Enrollment56 (estimated)
SponsorASST Fatebenefratelli Sacco
Academic / other
Locations1 site (Milano, Lombardy)
Trial IDNCT06123845 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.