Status:
COMPLETED
Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at <28 Weeks Gestation With a Persistent Patent Ductus Arteriosus
Lead Sponsor:
University of California, San Francisco
Conditions:
Patent Ductus Arteriosus
Eligibility:
All Genders
Up to 48 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to examine if a higher dose of indomethacin will increase the rate of ductus arteriosus closure in extremely premature infants without increasing the side effects. The lon...
Detailed Description
This study is a Phase II randomized, masked, controlled trial that compares the current standard dose of indomethacin to a higher dose for the closure of PDA in premature infants less than 28 weeks of...
Eligibility Criteria
Inclusion
- Newborn infants of less than 28 weeks gestational age who are treated with indomethacin during the first 48 hours after birth
- Presence of patent ductus arteriosus (PDA) by Doppler echocardiography between the second and third dose of indomethacin.
- Creatinine ≤1.8 mg/dl
- Platelets ≥ 50,000
Exclusion
- Chromosomal disorders.
- Major congenital anomalies.
- Contraindications for indomethacin
- Necrotizing enterocolitis, by clinical or radiological evidence
- Evidence of bleeding diathesis as evidenced by pulmonary hemorrhage, persistent oozing from puncture sites, grossly bloody stool (Note: Infants with an intracranial hemorrhage can be enrolled in this study).
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00187447
Start Date
August 1 2003
End Date
July 1 2006
Last Update
June 4 2008
Active Locations (3)
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1
University of California San Francisco
Davis, California, United States, 94143
2
University of Chicago
Chicago, Illinois, United States
3
Brown University
Providence, Rhode Island, United States