Clinical Trial

"Effectiveness of Delivery Room Bubble CPAP in Preterm Infants With Respiratory Distress

Enrolling by Invitation
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Summary
Background When babies are born too early (preterm), their lungs are often not fully developed. They may have trouble breathing because their airways and chest are not strong enough, and their lungs don't make enough surfactant (a natural substance that keeps the lungs open). This makes their tiny lungs collapse easily, causing breathing problems. Continuous Positive Airway Pressure (CPAP) is a safe and gentle way to help these babies breathe. CPAP works by sending a steady flow of air into the baby's nose, which keeps the lungs open and helps the baby breathe without needing a breathing machine (ventilator). The earlier CPAP is started after birth, the better it may help babies breathe more easily and reduce serious lung problems. Purpose of the Study This study will look at whether giving bubble CPAP to preterm babies immediately in the delivery room (within the first 10 minutes after birth) can lower the risk of breathing problems and death during their hospital stay. How the Study Will Be Done The research will take place at Bangabandhu Sheikh Mujib Medical University (BSMMU) in Dhaka. Babies born before 34 weeks of pregnancy who meet the study criteria will be included, with their parents' consent. Babies will be randomly divided into two groups: CPAP group - babies will be given bubble CPAP soon after birth in the delivery room. Control group - babies will receive only oxygen support in the delivery room. Both groups will then be moved to the Neonatal Intensive Care Unit (NICU) for further treatment as per hospital guidelines. The results will be compared to see which group had better outcomes. Expected Outcome We expect that starting bubble CPAP very early will help preterm babies breathe better, reduce the need for ventilators, and lower the risk of long-term breathing problems or death.
Trial Details
NCT Number NCT07162285
Lead Sponsor Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Conditions Respiratory Distress Syndrome, Newborn
Enrollment 52 participants
Start Date 2025-09
Primary Completion 2026-09 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2025-09-09