Status:
COMPLETED
Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
University of Pennsylvania
Women & Children's Hospital of Buffalo
Conditions:
Respiratory Distress Syndrome
Bronchopulmonary Dysplasia
Eligibility:
All Genders
7-10 years
Phase:
NA
Brief Summary
A research study that will evaluate if giving surfactant medication to premature babies weighing \< 1250 gm at birth during the second and third weeks of life will help their lungs. We are enrolling t...
Detailed Description
Pulmonary surfactant is required for normal lung function. Data from a previous study suggest that as many as 75% of chronically ventilated extremely low birthweight premature infants have at least on...
Eligibility Criteria
Inclusion
- Less than or equal to1250 gm birthweight
- Day 7-10 of life
- Intubated and mechanically ventilated at day 7-10 of life
Exclusion
- Infants intubated solely for apnea
- Serious congenital malformations
- Life expectancy \< 7 days from enrollment
- Pulmonary hemorrhage at time of enrollment
- Active air leak syndrome at time of enrollment
- Bilateral grade IV intracranial hemorrhage
- Postnatal systemic steroid therapy for lung disease
- Note: Prior surfactant therapy at birth is neither an inclusion nor exclusion criterion.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00208039
Start Date
September 1 2004
End Date
November 1 2007
Last Update
November 22 2007
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