Premature Birth Clinical Trial
Official title:
A Randomized Trial: Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants
The purpose of this study is to determine whether the immediate bolus strategy combined with early nasal CPAP (nCPAP) treatment could decrease the subsequent need for ventilation compared to the administration of surfactant prophylaxis at 15 minutes after birth with early nCPAP in premature infants.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 2 Years |
Eligibility |
Inclusion Criteria: - Premature infants born before 28 weeks' gestation - Premature infants born at 29 to 30 weeks' gestation who did not receive antenatal steroid were randomized before delivery Exclusion Criteria: - Infants died at delivery room |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara University Faculty of Medicine Department of Pediatrics | Ankara |
Lead Sponsor | Collaborator |
---|---|
Ankara University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ventilatory requirement | Infants with RDS may require mechanical ventilation. Mechinal ventilation causes volu- and barotrauma in the lungs and associated morbidities. The earlier surfactant is given, the better it works. So immediate surfactant prophylaxis given before the first breath may decrease the requirement for mechanical ventilation compared with surfactant prophylaxis given at 15 minutes of age after resuscitation and stabilization. | within the first 5 days of life | No |
Secondary | Pneumothorax | first 72 hours of life | No | |
Secondary | Pulmonary hemorrhage | first 72 hours of life | No | |
Secondary | patent ductus arteriosus | first one week | No | |
Secondary | necrotizing enterocolitis | first one month | No | |
Secondary | retinopathy of prematurity | first two months | No | |
Secondary | intraventricular hemorrhage | first one week | No | |
Secondary | bronchopulmonary dysplasia | first two months | No | |
Secondary | duration of hospitalization | one year | No | |
Secondary | mortality | one year | No |
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