CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,136 enrolled
Drug / intervention
magnesium sulfatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00014989
NCT00014989Phase 3Completed

Randomized Clinical Trial of the Beneficial Effects of Antenatal Magnesium Sulfate (BEAM)

The George Washington University Biostatistics Center·interventional·Posted Apr 18, 2001·Updated Jul 12, 2019

In Brief

A Phase 3 clinical trial evaluating magnesium sulfate for Cerebral Palsy and 4 related conditions. Completed, enrolled 2,136 participants across 17 sites.

Detailed 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.

Study Details

Timeline

Phase 3CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 18, 2001
Enrollment StartDec 1, 1997
Primary CompletionFeb 1, 2007
Study CompletionJun 1, 2007
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 25.2 years ago

Interventions

magnesium sulfatedrug