Infant, Premature Clinical Trial
— TIPPOfficial title:
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.
Status | Completed |
Enrollment | 1202 |
Est. completion date | March 2001 |
Est. primary completion date | March 1999 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 6 Hours |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico | Albuquerque | New Mexico |
United States | Emory University | Atlanta | Georgia |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio |
United States | University of Texas Southwestern Medical Center at Dallas | Dallas | Texas |
United States | Wayne State University | Detroit | Michigan |
United States | University of Miami | Miami | Florida |
United States | Stanford University | Palo Alto | California |
United States | Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
NICHD Neonatal Research Network | Medical Research Council of Canada, National Center for Research Resources (NCRR) |
United States,
Alfaleh K, Smyth JA, Roberts RS, Solimano A, Asztalos EV, Schmidt B; Trial of Indomethacin Prophylaxis in Preterms Investigators. Prevention and 18-month outcomes of serious pulmonary hemorrhage in extremely low birth weight infants: results from the tria — View Citation
Ambalavanan N, Baibergenova A, Carlo WA, Saigal S, Schmidt B, Thorpe KE; Trial of Indomethacin Prophylaxis in Preterms (TIPP) Investigators. Early prediction of poor outcome in extremely low birth weight infants by classification tree analysis. J Pediatr. — View Citation
Bassler D, Stoll BJ, Schmidt B, Asztalos EV, Roberts RS, Robertson CM, Sauve RS; Trial of Indomethacin Prophylaxis in Preterms Investigators. Using a count of neonatal morbidities to predict poor outcome in extremely low birth weight infants: added role o — View Citation
Clyman RI, Saha S, Jobe A, Oh W. Indomethacin prophylaxis for preterm infants: the impact of 2 multicentered randomized controlled trials on clinical practice. J Pediatr. 2007 Jan;150(1):46-50.e2. — View Citation
Kabra NS, Schmidt B, Roberts RS, Doyle LW, Papile L, Fanaroff A; Trial of Indomethacin Prophylaxis in Preterms Investigators. Neurosensory impairment after surgical closure of patent ductus arteriosus in extremely low birth weight infants: results from th — View Citation
Schmidt B, Asztalos EV, Roberts RS, Robertson CM, Sauve RS, Whitfield MF; Trial of Indomethacin Prophylaxis in Preterms (TIPP) Investigators. Impact of bronchopulmonary dysplasia, brain injury, and severe retinopathy on the outcome of extremely low-birth- — View Citation
Schmidt B, Davis P, Moddemann D, Ohlsson A, Roberts RS, Saigal S, Solimano A, Vincer M, Wright LL; Trial of Indomethacin Prophylaxis in Preterms Investigators. Long-term effects of indomethacin prophylaxis in extremely-low-birth-weight infants. N Engl J M — View Citation
Schmidt B, Roberts RS, Fanaroff A, Davis P, Kirpalani HM, Nwaesei C, Vincer M; TIPP Investigators. Indomethacin prophylaxis, patent ductus arteriosus, and the risk of bronchopulmonary dysplasia: further analyses from the Trial of Indomethacin Prophylaxis — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Death or Neurodevelopment Impairment | 18-22 Months Corrected Age | Yes | |
Secondary | Patent ductus arteriosus | 120 Days of Life | Yes | |
Secondary | Bronchopulmonary Dysplasia (BPD) | Chronic Lung Disease (CLD) | 120 Days of Life | Yes |
Secondary | Necrotizing enterocolitis (NEC) | 120 Days of Life | Yes | |
Secondary | Intracranial abnormalities | 120 Days of Life | Yes | |
Secondary | Retinopathy of Prematurity (ROP) | 18-22 Months Corrected Age | Yes | |
Secondary | Pulmonary hemorrhage | 120 Days of Life | Yes |
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