Trial Search Results

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

NICHD Neonatal Research Network

Collaborator: National Center for Research Resources (NCRR)

Stanford Investigator(s):

Intervention(s):

  • Drug: indomethacin
  • Drug: Indomethacin
  • Drug: Placebo

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

N/A - 6 Hours

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting