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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Collaborators: |
Medical Research Council of Canada National Center for Research Resources (NCRR) |
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00009646 |
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infant, Very Low Birth Weight Infant, Premature Ductus Arteriosus, Patent |
Drug: indomethacin Drug: Indomethacin Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP) |
| Enrollment: | 1202 |
| Study Start Date: | November 1993 |
| Study Completion Date: | March 2001 |
| Primary Completion Date: | March 1999 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Indomethacin
Indocid P.D.A., Merck Frosst, Kirkland, Que., Canada, and Merck, West Point, Pa.
|
Drug: indomethacin
Indocid P.D.A., Merck Frosst, Kirkland, Que., Canada, and Merck, West Point, Pa
Drug: Indomethacin
0.1 mg per kilogram of body weight
|
|
Placebo Comparator: Placebo
Saline solution
|
Drug: Placebo
0.1 mg per kilogram of body weight
|
Prophylactic indomethacin reduces patent ductus arteriosus (PDA) and intraventricular hemorrhage in very low birth weight infants. However, the effects of early indomethacin on long-term neurodevelopment remain uncertain. There is also insufficient evidence to rule out serious adverse effects, such as increases in the risk of necrotizing enterocolitis (NEC) and retinopathy of prematurity (ROP). The aim of this trial was to determine if prophylactic administration of indomethacin improves survival without neurosensory impairments in extremely-low-birth-weight infants. Infants (n=1202) with birthweights 500 to 999 grams were randomized between 2 and 6 hours after birth to receive either intravenous indomethacin (0.1 mg/kg) or equal volumes of normal saline placebo, daily for 3 days. The primary outcomes at a corrected age of 18 months was a composite of death, cerebral palsy, cognitive delay, deafness, or blindness. Secondary long-term outcomes were hydrocephalus necessitating the placement of a shunt, seizure disorder, and microcephaly. Secondary short-term outcomes were patent ductus arteriosus, pulmonary hemorrhage, chronic lung disease, cranial ultrasonographic abnormalities, nectrotizing enterocolitis and retinopathy. Infants were evaluated in follow-up at 18-22 months corrected age.
Eligibility| Ages Eligible for Study: | up to 6 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| Stanford University | |
| Palo Alto, California, United States, 94304 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30303 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, Ohio | |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Rhode Island | |
| Brown University, Women & Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75235 | |
| Study Director: | Barbara Schmidt, MD | McMaster University |
| Principal Investigator: | David K. Stevenson, MD | Stanford University |
| Principal Investigator: | Lu-Ann Papile, MD | University of New Mexico |
| Principal Investigator: | Jon E. Tyson, MD MPH | University of Texas |
| Principal Investigator: | Waldemar A. Carlo, MD | University of Alabama at Birmingham |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University |
| Principal Investigator: | Barbara J. Stoll, MD | Emory University |
| Principal Investigator: | Avroy A. Fanaroff, MD | Case Western Reserve University |
| Principal Investigator: | Charles R. Bauer, MD | University of Miami |
| Principal Investigator: | William Oh, MD | Brown University, Womens and Infants Hospital |
More Information
| Responsible Party: | Barbara Schmidt/ Lead Principal Investigator, McMaster University |
| ClinicalTrials.gov Identifier: | NCT00009646 History of Changes |
| Other Study ID Numbers: | NICHD-NRN-0011, U10HD034216, U10HD027904, U10HD021364, U10HD027851, U10HD021397, U10HD027881, U10HD027880, U10HD021373, U10HD021385, MT-13288, M01RR000997, M01RR000070 |
| Study First Received: | February 1, 2001 |
| Last Updated: | January 9, 2011 |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board; United States: Food and Drug Administration |
|
Chronic lung disease Indocin Indomethacin Infants, very low birth weight |
Intraventricular hemorrhage Necrotizing enterocolitis Patent ductus arteriosus Pulmonary hemorrhage |
|
Birth Weight Ductus Arteriosus, Patent Body Weight Signs and Symptoms Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities Indomethacin Gout Suppressants Antirheumatic Agents Therapeutic Uses Pharmacologic Actions |
Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Cardiovascular Agents Central Nervous System Agents |
