Management of Patent Ductus in Premature Infants
NCT00000494 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2013-12-13
Summary
To evaluate the effects (up to one year of age) of indomethacin on the clinical course of patent ductus arteriosus (PDA) in premature infants (24 hours old or less) and to assess the relative merits of indomethacin and surgery in infants with persistent respiratory distress who were not treated early with indomethacin. Two concurrent trials were performed.
Conditions
- Cardiovascular Diseases
- Defect, Congenital Heart
- Ductus Arteriosus, Patent
- Heart Diseases
Interventions
- DRUG
-
indomethacin
- PROCEDURE
-
surgery, cardiovascular
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
lead NIH
Principal Investigators
-
Alexander Nadas · Children's Hospital & Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
Eligibility
- Max Age
- 1 Year
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1978-09-30
- Completion
- 1982-03-31
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