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Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial

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ClinicalTrials.gov Identifier: NCT00033917
Recruitment Status : Completed
First Posted : April 15, 2002
Results First Posted : March 28, 2013
Last Update Posted : March 28, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in the brain of very low birth weight preterm infants.

Condition or disease Intervention/treatment Phase
Intraventricular Hemorrhage (IVH) Bleeding in the Brain Prematurity Very Low Birth Weight Infants Drug: indomethacin Drug: placebo Phase 3

Detailed Description:

Intraventricular hemorrhage (IVH) or bleeding in the brain remains a major problem of preterm infants. This randomized, placebo-controlled multicenter trial enrolled 505 infants of 600 to 1250g birth weight to determine if indomethacin lowers the incidence of IVH, and 125 term infant controls. During this longitudinal trial, follow-up assessments have been performed at the ages of 3, 4 1/2, 6, 8, 12 and 16 years. The initial results at age 3 years revealed no advantages to the indomethacin group over and above the decreases in IVH, however, the results did show a significant increase in ventriculomegaly in the "placebo" group. Results at 4 1/2, 6 and 8 years of age showed beneficial effects of indomethacin on cognitive and behavioral outcomes over and above the effects on preventing IVH but not at later ages. At 12 and 16 years, no significant influence of indomethacin on cognitive outcome was noted.

Age, gender and zip-code matched control subjects were added when the preterm subjects were 8 years. Throughout all subsequent testing, term controls have higher IQ and Peabody Picture Vocabulary Scores.

Additional longitudinal volumetric, functional and diffusion tensor MR imaging studies showed differences between preterm and term control subjects at 8, 12 and 16 years of age. These were consistent with utilization of the right hemisphere and left cerebellum for language in the preterm group compared to term controls. No effects of indomethacin were seen.

The study closed on 31 March 2012.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial
Study Start Date : September 1989
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
indomethacin
Drug: indomethacin
an anti-inflammatory drug
Placebo Comparator: 2
placebo
Drug: placebo
saline


Outcome Measures

Primary Outcome Measures :
  1. IVH at 5 Postnatal Days [ Time Frame: at 5 days ]
    Cranial ultrasounds were performed daily for the first 5 postnatal days; the main outcome measure was intraaventricular hemorrhage (IVH) at 5 days of age


Secondary Outcome Measures :
  1. Language Outcome [ Time Frame: at 8 years ]

    Peabody Picture Vocabulary Test (PPVT) This is a semantic language test. The mean value is 100; standard deviation is 16 points. A higher score means better language; a lower score means poorer language.

    There are no subscales to the PPVT. The measurement unit is points on a scale. A score < 70 indicates severely abnormal language function.



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • Preterm infants < 1250 g birth weight
  • Admitted to participating institution < 6 hrs of age
  • No evidence for congenital malformations
  • Cranial US at 6 postnatal hours without evidence of Grades III - IV intraventricular hemorrhage
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033917


Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States
United States, Maine
Maine Medical Center
Portland, Maine, United States
United States, Rhode Island
Brown University School of Medicine
Providence, Rhode Island, United States
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Laura R. Ment, M.D. Department of Pediatrics, Yale University School of Medicine
More Information

Publications:

Responsible Party: Laura R. Ment, Professor Pediatrics and Neurology, Yale University
ClinicalTrials.gov Identifier: NCT00033917     History of Changes
Other Study ID Numbers: R01NS027116 ( U.S. NIH Grant/Contract )
First Posted: April 15, 2002    Key Record Dates
Results First Posted: March 28, 2013
Last Update Posted: March 28, 2013
Last Verified: February 2013

Keywords provided by Laura R. Ment, Yale University:
intraventricular hemorrhage (IVH)
bleeding in the brain
indomethacin
prematurity
very low birth weight infants

Additional relevant MeSH terms:
Hemorrhage
Birth Weight
Premature Birth
Cerebral Hemorrhage
Pathologic Processes
Body Weight
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors