Clinical trial Recruiting at 1 site Interventional Ages 0 Minutes to 44 Weeks

Comparing two breathing support methods for preterm newborns with breathing difficulties

Official title: Randomized Control Trial: Nasal CPAP vs. NIPPV in Preterm Infants With Respiratory Distress Syndrome

Run by Vilnius University · NCT06966752 · Data updated 2026-11-12

This study is testing which breathing support method, CPAP or NIPPV, works better for preterm newborns with breathing problems to see which one helps them breathe easier and stay healthy.

Quick facts

Study typeInterventional
Ages0 Minutes to 44 Weeks
SexAll
Enrollment150 (estimated)
SponsorVilnius University
Academic / other
Locations1 site (Vilnius, Vilnius County)
StatusRecruiting
StartedMarch 25, 2025
Main results expectedMay 1, 2027
Study endsMay 1, 2027
Registry record updatedMay 13, 2025
Trial IDNCT06966752 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are preterm newborns with a gestational age between 22 and 34 weeks who require respiratory support.

Probably not a fit

Patients with major congenital anomalies or cardiovascular instability 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 study evaluates the safety and efficacy of Continuous Positive Airway Pressure (CPAP) versus Non-Invasive Positive Pressure Ventilation (NIPPV) in preterm newborns suffering from Respiratory Distress Syndrome (RDS). The primary objective is to determine which method has a lower treatment failure rate, while secondary objectives include assessing mortality rates, intubation rates, and various complication rates associated with each method. The study will also analyze performance across different gestational age groups to understand the best approach for varying levels of prematurity.

Why it matters

Potential benefit: If successful, this study could lead to improved respiratory support strategies for preterm newborns, potentially reducing treatment failures and associated complications.

How similar studies have gone: Previous studies have shown varying success with similar approaches, but this specific comparison of CPAP and NIPPV in preterm infants is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. gestational age (GA) between 22+0 and 34+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings).
2. Need of respiratory support (deemed by a clinician).

Exclusion Criteria:

1. Major congenital anomalies
2. Cardiovascular instability
3. Consent refused or not provided

Where it's running

  • Vilnius University Santaros Klinikos
    Vilnius, Vilnius County, Lithuania
    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.