At a glance
ClinicalIndex Comparison RecordPhase 3Completed
Drug / intervention
indomethacin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Management of Patent Ductus in Premature Infants
National Heart, Lung, and Blood Institute (NHLBI)·interventional·Posted Oct 28, 1999·Updated Dec 13, 2013
In Brief
A Phase 3 clinical trial evaluating indomethacin and surgery, cardiovascular for Cardiovascular Diseases and 3 related conditions. Completed.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Diseases, Defect, Congenital Heart, Ductus Arteriosus, Patent, Heart Diseases
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
19781979198019811982198319841985198619871988198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 1978
Study CompletionMar 1982
First PostedOct 1999
TodayJul 2026
First PostedOct 28, 1999
Enrollment StartSep 1, 1978
Study CompletionMar 1, 1982
TodayJul 2, 2026
Posted 26.7 years ago
Interventions
indomethacindrug
surgery, cardiovascularprocedure