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

NCT07162285 | Enrolling By Invitation DMC

• 1 other identifier: 4724
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Need for mechanical ventilation

  This outcome will allow assessment of whether delivery room bubble CPAP reduces respiratory complications with standard supplemental oxygen.

  From birth until 7 completed days of life

• Requirement for surfactant therapy

  This outcome will allow assessment of whether delivery room bubble CPAP reduces need for surfcatant with standard supplemental oxygen.

  From birth until 7 completed days of life

• Death within the early neonatal period

  This outcome will allow assessment of whether delivery room bubble CPAP reduces early mortality compared with standard supplemental oxygen.

  From birth until 7 completed days of life

Study Arms (2)

Delivery Room Bubble CPAP

EXPERIMENTAL

Preterm neonates (\<34 weeks gestation) with respiratory distress will receive bubble continuous positive airway pressure (bCPAP) initiated in the delivery room within 10 minutes of birth. The intervention will be delivered via nasal prongs with pressure settings titrated as per institutional protocol. The aim is to provide continuous distending pressure to stabilize alveoli, improve oxygenation, and reduce the need for intubation, surfactant, and mechanical ventilation.

Device: Delivery Room Bubble CPAP

Delivery Room Supplemental Oxygen

ACTIVE COMPARATOR

Preterm neonates (\<34 weeks gestation) with respiratory distress will receive supplemental oxygen therapy in the delivery room within 10 minutes of birth, administered by standard delivery methods (e.g., mask and oxygen flow). This group will serve as the comparator to evaluate whether early initiation of bubble CPAP improves respiratory outcomes compared to oxygen alone.

Other: Delivery Room Supplemental Oxygen

Interventions

Delivery Room Bubble CPAP DEVICE

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

Delivery Room Bubble CPAP

Delivery Room Supplemental Oxygen OTHER

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

Delivery Room Supplemental Oxygen

Eligibility Criteria

• Age: 5 Minutes - 30 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Neonate gestational age less than 34 weeks delivered at BSMMU. Having respiratory distress.

You may not qualify if:

• Congenital anomaly such as cleft lip, cleft palate, congenital diaphragmatic hernia.
• Newborn required delivery room intubation

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Nuzhat nuary Jui

Dhaka, 1229, Bangladesh

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Nuzhat Nuary, MBBS

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Model Details: Delivery Room Bubble CPAP Supplemental Oxygen (control)

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 9, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-08

Locations

BA (1)