Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)
BEAM
Randomized Clinical Trial of the Beneficial Effects of Antenatal Magnesium Sulfate (BEAM)
22 other identifiers
interventional
2,136
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 1997
Longer than P75 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1997
CompletedFirst Submitted
Initial submission to the registry
April 17, 2001
CompletedFirst Posted
Study publicly available on registry
April 18, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedJuly 12, 2019
July 1, 2019
9.2 years
April 17, 2001
July 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite outcome of death or moderate to severe cerebral palsy
Secondary Outcomes (13)
Maternal
Chorioamnionitis
Endometritis
Other infectious morbidity
Pulmonary edema
- +8 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
University of Alabama
Birmingham, Alabama, 35233, United States
Dept of OB/GYN, University of Miami
Miami, Florida, 33136, United States
Northwestern University
Chicago, Illinois, 60611, United States
Dept of OB/GYN, Hutzel Hospital
Detroit, Michigan, 48201, United States
St. Luke's - Roosevelt Hospital
New York, New York, 10019, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Forsyth Memorial Hospital, Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27103, United States
The University Hospital, University of Cincinnati
Cincinnati, Ohio, 45267-0794, United States
Case Western University
Cleveland, Ohio, 44109, United States
Dept of OB/GYN, Ohio State University
Columbus, Ohio, 43210, United States
MCP Hahnemann University
Philadelphia, Pennsylvania, 19102, United States
Dept of OB/GYN Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
Women and Infants Hospital
Providence, Rhode Island, 02905-2499, United States
Dept of OB/GYN, Southwestern Medical Center, University of Texas
Dallas, Texas, 75235-9032, United States
University of Texas Medical Branch - Galveston
Galveston, Texas, 77555, United States
University of Texas - Houston
Houston, Texas, 77030, United States
University of Utah Medical Center
Salt Lake City, Utah, 84132, United States
Related Publications (11)
Nelson KB, Grether JK. Can magnesium sulfate reduce the risk of cerebral palsy in very low birthweight infants? Pediatrics. 1995 Feb;95(2):263-9.
PMID: 7838646BACKGROUNDSchendel DE, Berg CJ, Yeargin-Allsopp M, Boyle CA, Decoufle P. Prenatal magnesium sulfate exposure and the risk for cerebral palsy or mental retardation among very low-birth-weight children aged 3 to 5 years. JAMA. 1996 Dec 11;276(22):1805-10.
PMID: 8946900BACKGROUNDHallak M, Berry SM, Madincea F, Romero R, Evans MI, Cotton DB. Fetal serum and amniotic fluid magnesium concentrations with maternal treatment. Obstet Gynecol. 1993 Feb;81(2):185-8.
PMID: 8423946BACKGROUNDAziz K, Vickar DB, Sauve RS, Etches PC, Pain KS, Robertson CM. Province-based study of neurologic disability of children weighing 500 through 1249 grams at birth in relation to neonatal cerebral ultrasound findings. Pediatrics. 1995 Jun;95(6):837-44.
PMID: 7761206BACKGROUNDPinto-Martin JA, Riolo S, Cnaan A, Holzman C, Susser MW, Paneth N. Cranial ultrasound prediction of disabling and nondisabling cerebral palsy at age two in a low birth weight population. Pediatrics. 1995 Feb;95(2):249-54.
PMID: 7838643BACKGROUNDRouse DJ, Hirtz DG, Thom E, Varner MW, Spong CY, Mercer BM, Iams JD, Wapner RJ, Sorokin Y, Alexander JM, Harper M, Thorp JM Jr, Ramin SM, Malone FD, Carpenter M, Miodovnik M, Moawad A, O'Sullivan MJ, Peaceman AM, Hankins GD, Langer O, Caritis SN, Roberts JM, for the Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units Network. A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy. New England Journal of Medicine, 359:895-905, 2008.
RESULTCostantine MM, Weiner SJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU). Effects of antenatal exposure to magnesium sulfate on neuroprotection and mortality in preterm infants: a meta-analysis. Obstet Gynecol. 2009 Aug;114(2 Pt 1):354-364. doi: 10.1097/AOG.0b013e3181ae98c2.
PMID: 19622997RESULTBuhimschi CS, Jablonski KA, Rouse DJ, Varner MW, Reddy UM, Mercer BM, Leveno KJ, Wapner RJ, Sorokin Y, Thorp JM Jr, Ramin SM, Malone FD, Carpenter MW, O'Sullivan MJ, Peaceman AM, Saade GR, Dudley D, Caritis SN, Buhimschi IA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Cord Blood Haptoglobin, Cerebral Palsy and Death in Infants of Women at Risk for Preterm Birth: A Secondary Analysis of a Randomised Controlled Trial. EClinicalMedicine. 2019 Mar 22;9:11-18. doi: 10.1016/j.eclinm.2019.03.009. eCollection 2019 Mar.
PMID: 31143877DERIVEDHirtz DG, Weiner SJ, Bulas D, DiPietro M, Seibert J, Rouse DJ, Mercer BM, Varner MW, Reddy UM, Iams JD, Wapner RJ, Sorokin Y, Thorp JM Jr, Ramin SM, Malone FD, Carpenter MW, O'Sullivan MJ, Peaceman AM, Hankins GD, Dudley D, Caritis SN; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Antenatal Magnesium and Cerebral Palsy in Preterm Infants. J Pediatr. 2015 Oct;167(4):834-839.e3. doi: 10.1016/j.jpeds.2015.06.067. Epub 2015 Aug 5.
PMID: 26254839DERIVEDTwickler DM, McIntire DD, Alexander JM, Leveno KJ. Effects of magnesium sulfate on preterm fetal cerebral blood flow using Doppler analysis: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):21-25. doi: 10.1097/AOG.0b013e3181c4f7c1.
PMID: 20027029DERIVEDRouse DJ, Hirtz DG, Thom E, Varner MW, Spong CY, Mercer BM, Iams JD, Wapner RJ, Sorokin Y, Alexander JM, Harper M, Thorp JM Jr, Ramin SM, Malone FD, Carpenter M, Miodovnik M, Moawad A, O'Sullivan MJ, Peaceman AM, Hankins GD, Langer O, Caritis SN, Roberts JM; Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units Network. A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy. N Engl J Med. 2008 Aug 28;359(9):895-905. doi: 10.1056/NEJMoa0801187.
PMID: 18753646DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2001
First Posted
April 18, 2001
Study Start
December 1, 1997
Primary Completion
February 1, 2007
Study Completion
June 1, 2007
Last Updated
July 12, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will share
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.