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Comparison of two types of breathing devices for preterm babies admitted in NICU.

Comparison Of Bubble CPAP (Variable Flow CPAP) Vs Pressure Sources Of CPAP In Preterm Infants An Open Labelled Randomized Controlled Trial. - NILL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/095995
Enrollment
100
Registered
2025-10-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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 (Variable flow CPAP system.): In this mode, continuous positive airway pressure is delivered to the preterm infant through a bubble CPAP circuit. The expiratory limb of the

Sponsors

AIIMS Bhopal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm (less than 37 completed weeks at birth) who develop early onset respiratory distress requiring CPAP within 6 hours of birth.

Exclusion criteria

Exclusion criteria: 1. Surgical anomalies of chest and abdomen 2. Syndromic newborns 3. Preterm infants who require delivery room intubation and early surfactant replacement therapy. 4. Perinatal asphyxia with encephalopathy or cord pH 5. Pneumothorax or air-leaks prior to enrolment

Design outcomes

Primary

MeasureTime frame
1.CPAP failure in the first 72 hours of birth 2.Need of mechanical ventilation 3.Incidence of hypoxic respiratory failure Timepoint: baseline data, 1 day, 3 days. 7 days, 14 days and 28 days

Secondary

MeasureTime frame
1.Duration of respiratory support. 2.Need for surfactant replacement therapy 3.Need of vasopressors in first 72 hours 4.Oxygenation assessment by Spo2/Fio2 for the first 72 hours after birth. 5.Incidence of common preterm morbidity like BPD, IVH, PDA,ROP,NEC, ect. 6.Incidence of complications of nasal trauma & air leaks. 7.Duration of oxygen supplementation. Timepoint: baseline, 1 day, 3 days, 7 days, 14 days & 28 days

Countries

India

Contacts

Public ContactDr Chetan Khare

AIIMS Bhopal

shikha.pediatrics@aiimsbhopal.edu.in9425018080

Outcome results

None listed

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