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NCT00014989 · ClinicalTrials.gov registry record · Phase 3
Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)
A Phase 3 study of Cerebral Palsy and Intraventricular Hemorrhage, sponsored by The George Washington University Biostatistics Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,136
- Enrollment target
- 17
- Study locations
NCT00014989 is a Phase 3 study of Cerebral Palsy and Intraventricular Hemorrhage that has completed, run by The George Washington University Biostatistics Center. The registered enrollment target is 2,136 participants, above the 206-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (937% higher). The trial reports 17 study locations across 11 states.
The verdict
NCT00014989, a Phase 3 study of Cerebral Palsy and Intraventricular Hemorrhage, has completed, sponsored by The George Washington University Biostatistics Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,136 participants
- Enrollment target
- 17
- Study locations
Study Summary
As many more premature infants survive, the numbers of these infants with health problems increases. The rate of cerebral palsy (CP) in extremely premature infants is approximately 20%. Magnesium sulfate, the most commonly used drug in the US to stop premature labor, may prevent CP. This trial tests whether magnesium sulfate given to a woman in labor with a premature fetus (24 to 31 weeks out of 40) will reduce the rate of death or moderate to severe CP in the children at 2 years. The children receive ultrasounds of their brains as infants and attend three follow-up visits over two years to assess their health and development.
Conditions Studied
Interventions
- DRUG magnesium sulfate
Study Locations (17)
Ohio
- The University Hospital, University of Cincinnati - Cincinnati
- Case Western University - Cleveland
- Dept of OB/GYN, Ohio State University - Columbus
Texas
- Dept of OB/GYN, Southwestern Medical Center, University of Texas - Dallas
- University of Texas Medical Branch - Galveston - Galveston
- University of Texas - Houston - Houston
North Carolina
- University of North Carolina - Chapel Hill
- Forsyth Memorial Hospital, Wake Forest University School of Medicine - Winston-Salem
Pennsylvania
- MCP Hahnemann University - Philadelphia
- Dept of OB/GYN Magee Womens Hospital - Pittsburgh
Alabama
- University of Alabama - Birmingham
Florida
- Dept of OB/GYN, University of Miami - Miami
Illinois
- Northwestern University - Chicago
Michigan
- Dept of OB/GYN, Hutzel Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,136 participants |
| Start Date | 1997-12 |
| Est. Completion | 2007-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00014989
The ClinicalTrials.gov registry entry for NCT00014989 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,136 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 206-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (937% higher). The listed sponsor is The George Washington University Biostatistics Center, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Cerebral Palsy appearing as the primary indexed condition, and to 1 intervention - of which magnesium sulfate is the first listed.
NCT00014989 reports 17 study locations spanning 11 distinct geographic areas - top geographies include Ohio, Texas, North Carolina.
Frequently Asked Questions
What is clinical trial NCT00014989 about?
NCT00014989 is a clinical study titled "Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)". As many more premature infants survive, the numbers of these infants with health problems increases. The rate of cerebral palsy (CP) in extremely premature infants is approximately 20%. Magnesium sulfate, the most commonly used drug in the US to stop premature labor, may prevent CP. This trial tests...
What is the current status of trial NCT00014989?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,136 participants. The study started on 1997-12. Estimated completion is 2007-06.
What conditions does trial NCT00014989 study?
This clinical trial studies the following conditions: Cerebral Palsy, Intraventricular Hemorrhage, Pulmonary Edema, Periventricular Leukomalacia, Abruptio Placentae.
What interventions are being tested in trial NCT00014989?
The interventions under investigation include: magnesium sulfate (DRUG).
Who is sponsoring clinical trial NCT00014989?
This trial is sponsored by The George Washington University Biostatistics Center, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00014989 being conducted?
This trial has 17 study locations across Alabama, Florida, Illinois, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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