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Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)
This study is currently recruiting patients.
Sponsored by: | National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institute of Child Health and Human Development (NICHD) |
Purpose
As many more premature infants survive, the numbers of these infants with health problems also has increased. The rate of cerebral palsy in extremely premature infants is approximately 20%. Magnesium sulfate, the most commonly used drug in the US used 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.
Condition | Treatment or Intervention | Phase |
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Cerebral Palsy Intraventricular hemorrhage Periventricular Leukomalacia Pulmonary Edema Abruptio Placentae |
Drug: magnesium sulfate |
Phase III |
MedlinePlus related topics: Brain Diseases; Cerebral Palsy; High Risk Pregnancy; Premature Babies; Respiratory Diseases; Stroke
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: Randomized Clinical Trial of the Beneficial Effects of Antenatal Magnesium Sulfate (BEAM)
Expected Total Enrollment: 2000
Study start: December 1997
The prevalence of cerebral palsy is increasing as the survival rate of extremely premature infants is improving. Studies have suggested an apparent association between maternal magnesium sulfate administration and a reduced risk of cerebral palsy. Other studies have suggested a possible association between magnesium sulfate and a reduction in neonatal cranial ultrasound abnormalities which may be markers for subsequent development of cerebral palsy.
This multicenter trial tests whether prophylactic magnesium sulfate given to women, for whom preterm delivery is imminent, reduces the risk of death or moderate to severe cerebral palsy in their children. Women presenting from 24.0 to 31.6 weeks gestation with advanced preterm labor or premature rupture of the membranes (pPROM) and no recent exposure to magnesium sulfate are randomized to receive (either intravenous magnesium sulfate or masked study drug placebo). No other parenteral tocolytics other than the IV medication may be used. Retreatment with study medication is given any time labor recurs or delivery is anticipated until gestational age is > 34.0 wks. Standard clinical management and therapy is to be maintained for all study patients. Patients are assessed for signs of intolerance to the study medications and maternal data are collected up to hospital discharge. A sample of venous blood is collected and neonatal cranial ultrasounds are performed. Up to three follow-up visits are scheduled over two years where certified examiners, masked to study group assignment, collect physical and neurological data, including a modified Gross Motor Function Classification Scale. The Bayley Scales of Infant Development is also administered. Cranial ultrasounds are reviewed centrally.
The primary outcome is a composite outcome of death or moderate to severe cerebral palsy. Secondary outcomes include maternal infectious morbidity, pulmonary edema and placental abruption, neonatal stillbirth and death, intraventricular hemorrhage, periventricular leukomalacia, neonatal infectious and noninfectious morbidity.
Eligibility
Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
Exclusion Criteria:
Location and Contact Information
More Information
Click here for more information about trials at NICHD.
Click here for more information on the NICHD MFMU Research Network.
Publications
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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