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

NCT07162285 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-09-09

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome, Newborn

Interventions

DEVICE

Delivery Room Bubble CPAP

delivery room bubble CPAP initiated within 10 minutes of birth for preterm neonates \<34 weeks, using water-seal oscillation system via nasal prongs.

OTHER

Delivery Room Supplemental Oxygen

Standard oxygen therapy initiated within 10 minutes of birth via mask/tubing, without positive pressure support.

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Principal Investigators

  • Nuzhat Nuary, MBBS · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Minutes
Max Age
30 Minutes
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-09-30
Completion
2026-10-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07162285 on ClinicalTrials.gov