Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)

Trial ID or NCT#

NCT00009646

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)

Eligibility Criteria

Ages Eligible for Study: 2 Hours to 6 Hours
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Birth weight 500 to 999 grams; - Postnatal age greater than 2 hours;
Exclusion Criteria:
  1. - 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
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Investigator(s)

David K. Stevenson, M.D.

View on ClinicalTrials.gov