Comparing two breathing support methods for preterm newborns with breathing difficulties
Randomized Control Trial: Nasal CPAP vs. NIPPV in Preterm Infants With Respiratory Distress Syndrome
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 0 Minutes to 44 Weeks |
| Sex | All |
| Sponsor | Vilnius University Academic / other |
| Locations | 1 site (Vilnius, Vilnius County) |
| Trial ID | NCT06966752 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are preterm newborns with a gestational age between 22 and 34 weeks who require respiratory support.
Not a fit: Patients with major congenital anomalies or cardiovascular instability will not benefit from this study.
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 performed: Previous studies have shown varying success with similar approaches, but this specific comparison of CPAP and NIPPV in preterm infants is relatively novel.
Eligibility criteria
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 this trial is running
Vilnius, Vilnius County
- Vilnius University Santaros Klinikos — Vilnius, Vilnius County, Lithuania (Recruiting)
Study contacts
- Study coordinator: Arunas Liubsys, Associate Professor
- Email: arunas.liubsys@santa.lt
- Phone: +370 6 872 2520
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.