Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP) (TIPP)
Infant, Very Low Birth Weight, Infant, Premature, Ductus Arteriosus, Patent
About this trial
This is an interventional prevention trial for Infant, Very Low Birth Weight focused on measuring Chronic lung disease, Indocin, Indomethacin, Infants, very low birth weight, Intraventricular hemorrhage, Necrotizing enterocolitis, Patent ductus arteriosus, Pulmonary hemorrhage
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham
- Stanford University
- University of Miami
- Emory University
- Wayne State University
- University of New Mexico
- Case Western Reserve University, Rainbow Babies and Children's Hospital
- Brown University, Women & Infants Hospital of Rhode Island
- University of Texas Southwestern Medical Center at Dallas
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Indomethacin
Placebo
Indocid P.D.A., Merck Frosst, Kirkland, Que., Canada, and Merck, West Point, Pa.
Saline solution