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RECRUITING
NCT06966752
NA

Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.

Sponsor: Vilnius University

View on ClinicalTrials.gov

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

Interventions

OTHER

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.

OTHER

CPAP

CPAP pressure of 6-8 mmH2O

Locations (1)

Vilnius University Santaros Klinikos

Vilnius, Vilnius County, Lithuania