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Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)

NCT00014989 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2136

Last updated 2019-07-12

No results posted yet for this 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

  • Cerebral Palsy
  • Intraventricular Hemorrhage
  • Periventricular Leukomalacia
  • Pulmonary Edema
  • Abruptio Placentae

Interventions

DRUG

magnesium sulfate

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • The George Washington University Biostatistics Center

    lead OTHER

Principal Investigators

  • Dwight Rouse, MD · University of Alabama at Birmingham

  • Menachem Miodovnik · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-12-31
Primary Completion
2007-02-28
Completion
2007-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00014989 on ClinicalTrials.gov