Status:
COMPLETED
Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With Respiratory Decompensation
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
University of Pennsylvania
Women & Children's Hospital of Buffalo
Conditions:
Respiratory Distress Syndrome
Eligibility:
All Genders
7-10 years
Phase:
NA
Brief Summary
The purpose of the study is to determine whether additional surfactant(Infasurf) doses at 7 to 10 days of life time will improve lung function in premature infants, allowing a decrease in required oxy...
Detailed Description
Pulmonary surfactant is required for normal lung function. Preliminary data from previous trials suggest that more than half of chronically ventilated premature infants, greater than 1 week of age, ha...
Eligibility Criteria
Inclusion
- Less than 1250 gm birthweight
- Day 5-21 of life
- Intubated and mechanically ventilated, with respiratory decompensation, defined as the majority of daily severity scores (calculated every 6 hr from average of respiratory settings over 3-4 hour period) rising from baseline \< 1.8, to \> 3.5, sustained for \>24hr. Note: Prior surfactant therapy at birth is neither an inclusion nor exclusion criterion.
Exclusion
- Serious congenital malformations
- Life expectancy \< 7 days from enrollment
- Patent ductus arteriosus at time of decompensation
- Pulmonary hemorrhage as cause of respiratory decompensation
- Active air leak syndrome at time of decompensation
- Postnatal steroid therapy for lung disease
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00165074
Start Date
June 1 2003
End Date
June 1 2007
Last Update
November 22 2007
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