Early Surfactant Therapy to prevent need for ventilation for preterm infants(gestation <34weeks)on Bubble CPAP.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Preterm infants with Respiratory distress syndrome
- Registration Number
- CTRI/2008/091/000234
- Lead Sponsor
- o sponsor
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 144
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
1)Severe asphyxia 5min apgar <3
2) Infants requiring intubation at birth
3)Lethal Congenital Malformations
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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: