Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.
Recruiting now · Not applicable
Conditions studied: Respiratory Distress Syndrome (RDS)
In brief
Primary objective: to evaluate safety and efficacy of two different non-invasive respiratory support modalities in preterm neonatal patients with respiratory distress syndrome. Secondary objective is to compare different respiratory support mode performance in different gestational age groups. Primary endpoint is treatment failure. With this study, the following hypotheses will be tested: Hypothesis 1: NIPPV has a lower failure rate compared to CPAP mode. Hypothesis 2: NIPPV complication rate is non-superior compared to CPAP.
Key facts
- Study ID
- NCT06966752
- Run by
- Vilnius University
- People needed
- 150
- Starts
- 2025-03-25
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2025-05-13
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- gestational age (GA) between 22+0 and 34+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings).
- Need of respiratory support (deemed by a clinician).
You may not qualify if…
- Major congenital anomalies
- Cardiovascular instability
- Consent refused or not provided
Where it is running
- Vilnius University Santaros Klinikos — Vilnius, Vilnius County, Lithuania (enrolling)
Full record on ClinicalTrials.gov
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