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Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial) (BEAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00014989
Recruitment Status : Completed
First Posted : April 18, 2001
Last Update Posted : July 12, 2019
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

Brief 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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Intraventricular Hemorrhage Periventricular Leukomalacia Pulmonary Edema Abruptio Placentae Drug: magnesium sulfate Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2136 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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





Primary Outcome Measures :
  1. Composite outcome of death or moderate to severe cerebral palsy

Secondary Outcome Measures :
  1. Maternal
  2. Chorioamnionitis
  3. Endometritis
  4. Other infectious morbidity
  5. Pulmonary edema
  6. Placental abruption
  7. Neonatal
  8. Stillbirth and neonatal death
  9. Intraventricular hemorrhage
  10. Neonatal infectious morbidity
  11. Neonatal noninfectious morbidity
  12. Birth weight
  13. Days in NICU


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Show Show 17 study locations
Sponsors and Collaborators
The George Washington University Biostatistics Center
National Institute of Neurological Disorders and Stroke (NINDS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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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)
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT00014989    
Other Study ID Numbers: NICHD-0800
U10HD021414 ( U.S. NIH Grant/Contract )
U10HD021410 ( U.S. NIH Grant/Contract )
U10HD027905 ( U.S. NIH Grant/Contract )
U10HD027917 ( U.S. NIH Grant/Contract )
U10HD027860 ( U.S. NIH Grant/Contract )
U10HD027915 ( U.S. NIH Grant/Contract )
U10HD034116 ( U.S. NIH Grant/Contract )
U10HD034208 ( U.S. NIH Grant/Contract )
U10HD034136 ( U.S. NIH Grant/Contract )
U10HD027869 ( U.S. NIH Grant/Contract )
U10HD036801 ( U.S. NIH Grant/Contract )
U10HD027861 ( U.S. NIH Grant/Contract )
U10HD034122 ( U.S. NIH Grant/Contract )
U10HD034210 ( U.S. NIH Grant/Contract )
U10HD040500 ( U.S. NIH Grant/Contract )
U10HD040485 ( U.S. NIH Grant/Contract )
U10HD053097 ( U.S. NIH Grant/Contract )
U10HD040544 ( U.S. NIH Grant/Contract )
U10HD040545 ( U.S. NIH Grant/Contract )
U10HD040560 ( U.S. NIH Grant/Contract )
U10HD040512 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2001    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be shared after completion and publication of the main analyses in accordance with NIH policy. The dataset can be obtained by email at mfmudatasets@bsc.gwu.edu.
Keywords provided by The George Washington University Biostatistics Center:
Preterm delivery
Cerebral palsy
Magnesium sulfate
Additional relevant MeSH terms:
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Pulmonary Edema
Cerebral Palsy
Leukomalacia, Periventricular
Abruptio Placentae
Hemorrhage
Pathologic Processes
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lung Diseases
Respiratory Tract Diseases
Cerebrovascular Disorders
Encephalomalacia
Vascular Diseases
Cardiovascular Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants