Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)

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.

Conditions

• Infant, Very Low Birth Weight
• Infant, Premature
• Ductus Arteriosus, Patent

Interventions

DRUG

indomethacin

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

DRUG

Indomethacin

0.1 mg per kilogram of body weight

DRUG

Placebo

0.1 mg per kilogram of body weight

Sponsors & Collaborators

• Medical Research Council of Canada

  collaborator OTHER

• National Center for Research Resources (NCRR)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Barbara Schmidt, MD · McMaster University

• David K. Stevenson, MD · Stanford University

• Lu-Ann Papile, MD · University of New Mexico

• Jon E. Tyson, MD MPH · University of Texas

• Waldemar A. Carlo, MD · University of Alabama at Birmingham

• Seetha Shankaran, MD · Wayne State University

• Barbara J. Stoll, MD · Emory University

• Avroy A. Fanaroff, MD · Case Western Reserve University

• Charles R. Bauer, MD · University of Miami

• William Oh, MD · Brown University, Womens and Infants Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Hours

Max Age

6 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1993-11-30

Primary Completion

1999-03-31

Completion

2001-03-31

Countries

• United States

Study Locations