Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial) (BEAM)
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|ClinicalTrials.gov Identifier: NCT00014989|
Recruitment Status : Completed
First Posted : April 18, 2001
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy Intraventricular Hemorrhage Periventricular Leukomalacia Pulmonary Edema Abruptio Placentae||Drug: magnesium sulfate||Phase 3|
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. The study drug is administered as a 6 gram loading dose followed by a 2 gram/hour infusion (or equivalent rate for placebo). If after 12 hours, delivery has not occurred and is not anticipated, the infusion is stopped. 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2136 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomized Clinical Trial of the Beneficial Effects of Antenatal Magnesium Sulfate (BEAM)|
|Study Start Date :||December 1997|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||June 2007|
- Composite outcome of death or moderate to severe cerebral palsy
- Other infectious morbidity
- Pulmonary edema
- Placental abruption
- Stillbirth and neonatal death
- Intraventricular hemorrhage
- Neonatal infectious morbidity
- Neonatal noninfectious morbidity
- Birth weight
- Days in NICU
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00014989
|Principal Investigator:||Dwight Rouse, MD||University of Alabama at Birmingham|
|Study Director:||Menachem Miodovnik||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|