CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,202 enrolled
Drug / intervention
indomethacin +2 moredrug
Likely dose
Indomethacin 0.1 mgfrom 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.

Search/NCT00009646
NCT00009646Phase 3Completed
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Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)

NICHD Neonatal Research Network·interventional·Posted Feb 5, 2001·Updated Jun 8, 2015

In Brief

A Phase 3 clinical trial evaluating indomethacin, Indomethacin, and 1 other intervention for Infant, Very Low Birth Weight and 2 related conditions. Completed, enrolled 1,202 participants across 9 sites.

Detailed Summary

This trial was to determine whether giving low-dose indomethacin to infants weight 500 to 999 grams (approximately 1 to 2 pounds) at birth improves their survival without cerebral palsy or developmental problems at 18 to 22 months of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfant, Very Low Birth Weight, Infant, Premature, Ductus Arteriosus, Patent
CountriesUnited States
CollaboratorsMedical Research Council of Canada, National Center for Research Resources (NCRR)

Timeline

Phase 3CompletedFinished
19931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 5, 2001
Enrollment StartNov 1, 1993
Primary CompletionMar 1, 1999
Study CompletionMar 1, 2001
TodayJul 1, 2026
Enrollment to primary: 5.3 yearsPosted 25.4 years ago

Interventions

indomethacindrug

Indocid P.D.A., Merck Frosst, Kirkland, Que., Canada, and Merck, West Point, Pa

Indomethacindrug

0.1 mg per kilogram of body weight

Placebodrug

0.1 mg per kilogram of body weight