Randomized Control Trial: Nasal CPAP vs. NIPPV in Preterm Infants With Respiratory Distress Syndrome
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 10 months
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
Lithuania
Vilnius University Santaros Klinikos
RECRUITING
Vilnius
Contact Information
Primary
Arunas Liubsys, Associate Professor
arunas.liubsys@santa.lt
+370 6 872 2520
Backup
Ernestas Virsilas
ernestas.virsilas@santa.lt
+37060787438
Time Frame
Start Date: 2025-03-25
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 150
Treatments
Active_comparator: CPAP
Patients under CPAP respiratory support.
Experimental: NIPPV
Patients under Noninvasive positive pressure ventilation (NIPPV).
Related Therapeutic Areas
Sponsors
Leads: Vilnius University