Actively Recruiting
Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.
Led by Vilnius University · Updated on 2025-05-13
150
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age between 22+0 and 34+6 weeks based on postmenstrual date and early ultrasound
- Need for respiratory support as determined by a clinician
You will not qualify if you...
- Major congenital anomalies
- Cardiovascular instability
- Consent refused or not provided
AI-Screening
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Trial Site Locations
Total: 1 location
1
Vilnius University Santaros Klinikos
Vilnius, Vilnius County, Lithuania, 08661
Actively Recruiting
Research Team
A
Arunas Liubsys, Associate Professor
CONTACT
E
Ernestas Virsilas
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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