Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)

• Status: Completed
• Trial end date: 2001-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NICHD Neonatal Research Network
• Collaborators: Medical Research Council of Canada; National Center for Research Resources (NCRR)
• Treatments: Indomethacin

Criteria

Inclusion Criteria:

• Birth weight 500 to 999 grams;

• Postnatal age greater than 2 hours;

Exclusion Criteria:

• 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