Respiratory Distress Syndrome Clinical Trial
Official title:
Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With
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 oxygen concentration and ventilator settings.
Status | Completed |
Enrollment | 11 |
Est. completion date | June 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 10 Days |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | University of Pennsylvania, Women & Children's Hospital of Buffalo |
Merrill JD, Ballard RA, Cnaan A, Hibbs AM, Godinez RI, Godinez MH, Truog WE, Ballard PL. Dysfunction of pulmonary surfactant in chronically ventilated premature infants. Pediatr Res. 2004 Dec;56(6):918-26. Epub 2004 Oct 20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | We hypothesize that at least 25% of treated infants will have a 50% or greater reduction in respiratory severity score at 72 hours compared to pre-treat | 72 hours |
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