Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)

Completed · Phase 3 · Has a placebo group

Conditions studied: Infant, Very Low Birth Weight, Infant, Premature, Ductus Arteriosus, Patent

In brief

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.

Key facts

Study ID

NCT00009646

Run by

NICHD Neonatal Research Network

People needed

1202

Starts

1993-11-01

Expected to finish

2001-03-01

Last updated by the study team

2015-06-08

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Birth weight 500 to 999 grams;
• Postnatal age greater than 2 hours;

You may not qualify if…

• Unable to administer study drug within 6 hours of birth;
• Structural heart disease and/or renal disease;
• Dysmorphic features or congenital abnormalities;
• Tocolytic therapy with indomethacin or other prostaglandin inhibitor within 72 hours prior to delivery;
• Overt clinical bleeding from more than one site;
• Platelet count less than 50 x 109/L;
• Hydrops;
• Not considered viable

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Stanford University — Palo Alto, California, United States
• University of Miami — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Wayne State University — Detroit, Michigan, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Brown University, Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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