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Early Surfactant Therapy to prevent need for ventilation for preterm infants(gestation <34weeks)on Bubble CPAP.

Randomized controlled trial of Early rescue versus Late rescue surfactant therapy in moderately preterm neonates receiving nasal Continuous Positive Airway Pressure (CPAP) for Respiratory Distress Syndrome.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2008/091/000234
Enrollment
144
Registered
2009-05-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Preterm infants with Respiratory distress syndrome

Interventions

Intervention1: Early surfactant: Curosurf 1.5ml at starting of CPAP and within 2hours of life Control Intervention1: Late Surfactant: 1.5ml Curosurf after 2 hours if FiO2 requirement is &gt
50% on CPAP

Sponsors

No sponsor
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants with gestational age 28 weeks to 33 weeks treated for RDS with Nasal Bubble CPAP with CXR suggestive of RDS

Exclusion criteria

Exclusion criteria: 1) Severe asphyxia 5min apgar <3 2) Infants requiring intubation at birth 3) Lethal Congenital Malformations

Design outcomes

Secondary

MeasureTime frame
The incidence of pneumothorax, pulmonary hemorrhage, patent ductus arteriosus (PDA) and necrotizing enterocolitis (NEC). Chronic Lung Disease, Duration of Oxygen Requirement and Duration of HospitalizationTimepoint:—

Primary

MeasureTime frame
The need for mechanical ventilation. Indication for ventilation will be PEEP requirement > 7cms and FiO2 requirement > 70%, Severe Apnea defined as >4 episodes per hour or need for bag and mask ventilation > 2 times per hour.Timepoint: During the first 7 days of life—

Countries

India

Contacts

Public Contactsrinvas murki
drhema4@gmail.com04024756997

Outcome results

None listed

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