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NCT00009646 · ClinicalTrials.gov registry record · Phase 3

Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)

A Phase 3 study, sponsored by NICHD Neonatal Research Network.

Completed
Registry status
Phase 3
Development phase
1,202
Enrollment target

NCT00009646: Completed Phase 3 study, sponsored by NICHD Neonatal Research Network.

NCT00009646 is a Phase 3 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 1,202 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00009646, a Phase 3 study, has completed, sponsored by NICHD Neonatal Research Network.

COMPLETED
Registry status
Phase 3
Development phase
1,202 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Indomethacin
  • DRUG indomethacin

Trial Details

FieldValue
Enrollment Target 1,202 participants
Start Date 1993-11
Est. Completion 2001-03
Phase Phase 3
NICHD Neonatal Research Network

61 total trials

What the finished NCT00009646 record still lists

NCT00009646 is an interventional study that assigns participants to a tested intervention. Its 1,202 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00009646 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00009646 about?

NCT00009646 is a clinical study titled "Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)". 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.

What is the current status of trial NCT00009646?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,202 participants. The study started on 1993-11. Estimated completion is 2001-03.

What interventions are being tested in trial NCT00009646?

The interventions under investigation include: Placebo (DRUG), Indomethacin (DRUG), indomethacin (DRUG).

Who is sponsoring clinical trial NCT00009646?

This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00009646's enrollment target sits among peer trials

1,202 220th of 2000 higher than 1,781 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00009646, the US trial registry maintained by the National Library of Medicine. NCT00009646 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.