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Bubble CPAP versus Ventilator CPAP in premature babies

A randomised controlled trial comparing the efficacy of Bubble Continuous Positive Airway Pressure (B-CPAP) and Ventilator Continuous Positive Airway Pressure (V-CPAP) in preterm neonates with respiratory distress - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/098134
Enrollment
160
Registered
2025-11-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P220- Respiratory distress syndrome of newborn

Interventions

Intervention1: Bubble CPAP: Bubble CPAP (Fischer and Paykel company)adminitered through nasal prongs till the condition improves or needs escalation to the next step of management Control Intervention

Sponsors

Dr Devi Pilakkal Gangadharan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates less than 72 hours of age and born between 28 and 36 weeks and 6 days of gestation with respiratory distress (Downe s score more than or equal to 3) will be included in the study.

Exclusion criteria

Exclusion criteria: Babies with either of the following will be excluded: 1. Congenital diaphragmatic hernia 2. Severe external congenital anomalies 3. Cardiac defects 4. Any respiratory support given outside hospital apart from oxygen 5. Surgical cases

Design outcomes

Primary

MeasureTime frame
To compare the CPAP success rate between Bubble CPAP and Ventilator CPAP as the initial mode of respiratory support for preterm babies with respiratory distress. Timepoint: 72 hours

Secondary

MeasureTime frame
1. To compare the change in SOPI between bubble CPAP and Ventilator CPAP as the initial mode of respiratory support for preterm babies with respiratory distress up to 72 hours after initiation of treatment. Timepoint: 72 hours after initiation;2. To compare the adverse outcomes between Bubble CPAP & Ventilator CPAP during the treatment period.Timepoint: 4-6 weeks;3. To compare the duration of respiratory support among babies treated with either bubble CPAP & ventilator CPAP for respiratory distress.Timepoint: 4-6 weeks

Countries

India

Contacts

Public ContactDr Deepti Thandaveshwar

JSS Medical College

deeptiadarsh@gmail.com9845023309

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026