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Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.
Sponsor: Vilnius University
Summary
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.
Official title: Randomized Control Trial: Nasal CPAP vs. NIPPV in Preterm Infants With Respiratory Distress Syndrome
Key Details
Gender
All
Age Range
0 Minutes - 44 Weeks
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-03-25
Completion Date
2027-05-01
Last Updated
2025-05-13
Healthy Volunteers
No
Conditions
Interventions
NIPPV
NIPPV * PEEP 6-8 cmH2O * PIP: 14-16 cmH2O * Tinsp: 0.3-0.5sec * \<28 weeks GA: 0.3 - 0.4 sec * \>28weeks GA: 0.4 - 0.5 sec * Rate: 20-35 breaths per minute.
CPAP
CPAP pressure of 6-8 mmH2O
Locations (1)
Vilnius University Santaros Klinikos
Vilnius, Vilnius County, Lithuania