Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The George Washington University Biostatistics Center
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Magnesium Sulfate

Criteria

Inclusion Criteria:

• Pregnant with diagnosis of preterm labor

• Membrane rupture or delivery definitely planned within 24 hours

• Gestational age > 24.0 and < 31.6 wks, viable fetus

Exclusion Criteria:

• Prior IV magnesium sulfate therapy within 12 hours of screening

• Delivery expected <2 hrs

• Cervical dilation > 8 cm

• More than 2 fetuses

• Known major fetal anomalies

• Hypertension or preeclampsia

• Maternal medical complications contraindicating magnesium sulfate treatment

• Participation in any intervention study which influences infant neurological outcome

• Previous participation in this trial