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 type | Interventional |
|---|---|
| Ages | 0 Minutes to 44 Weeks |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Vilnius University Academic / other |
| Locations | 1 site (Vilnius, Vilnius County) |
| Status | Recruiting |
| Started | March 25, 2025 |
| Main results expected | May 1, 2027 |
| Study ends | May 1, 2027 |
| Registry record updated | May 13, 2025 |
| Trial ID | NCT06966752 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
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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
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.
-
Breathing patterns in preterm infants before and after extubation.
This will try to see if measuring work of breathing with soft chest and abdominal bands can predict which intubated premature infants (≤32 weeks) will tolerate removal of their breathing tube.
-
Comparing calfactant and poractant alfa delivered by a less invasive catheter to treat respiratory distress in very preterm infants
This will see if poractant alfa or calfactant given through a thin catheter (LISA) helps preterm infants under 30 weeks with respiratory distress who are breathing on noninvasive support.
-
Early prediction of lung injury in very preterm infants using EIT and lung ultrasound
This project will test whether bedside Electrical Impedance Tomography (EIT) and lung ultrasound in stable preterm babies on non-invasive breathing support can spot uneven lung ventilation that predicts severe BPD or death by 36 weeks postmenstrual age.
-
Co-designed pain and sedation protocol for adults on ECMO
This project will test a co-designed pain and sedation plan to see if it's acceptable for adults receiving ECMO and similar ventilated ICU patients.
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Investigating Biomarkers in Acute Respiratory Distress Syndrome
This study is trying to see if certain markers in the blood can help us understand how Acute Respiratory Distress Syndrome affects the lungs and how severe the condition is in patients.
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.