Status:
TERMINATED
Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure
Lead Sponsor:
University of Utah
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Patent Ductus Arteriosus
Prematurity
Eligibility:
All Genders
Up to 96 years
Phase:
NA
Brief Summary
The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA cl...
Detailed Description
Infants with birth weight at \<1200gm and/or \<28 weeks gestation who have been diagnosed with a Patent Ductus Arteriosus (PDA) qualify for the study if there are no contraindications to treatment. In...
Eligibility Criteria
Inclusion
- Birth weight less than 1200gm
- Less than 28 weeks gestational age
- Confirmed Patent Ductus Arteriosus (PDA) via echocardiogram and clinical exam
Exclusion
- Active Bleeding
- Currently being treated for Persistent Pulmonary Hypertension (PPHN)
- Cardiac anomalies
- Chromosomal abnormalities
- Endocrine, metabolic, renal, or hepatic disorders
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00833365
Start Date
January 1 2009
End Date
November 1 2011
Last Update
July 4 2016
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84132