search
Back to results

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

Primary Purpose

Cerebral Palsy, Intraventricular Hemorrhage, Periventricular Leukomalacia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
magnesium sulfate
Sponsored by
The George Washington University Biostatistics Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebral Palsy focused on measuring Preterm delivery, Cerebral palsy, Magnesium sulfate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • Dept of OB/GYN, University of Miami
  • Northwestern University
  • Dept of OB/GYN, Hutzel Hospital
  • St. Luke's - Roosevelt Hospital
  • University of North Carolina
  • Forsyth Memorial Hospital, Wake Forest University School of Medicine
  • The University Hospital, University of Cincinnati
  • Case Western University
  • Dept of OB/GYN, Ohio State University
  • MCP Hahnemann University
  • Dept of OB/GYN Magee Womens Hospital
  • Women and Infants Hospital
  • Dept of OB/GYN, Southwestern Medical Center, University of Texas
  • University of Texas Medical Branch - Galveston
  • University of Texas - Houston
  • University of Utah Medical Center

Outcomes

Primary Outcome Measures

Composite outcome of death or moderate to severe cerebral palsy

Secondary Outcome Measures

Maternal
Chorioamnionitis
Endometritis
Other infectious morbidity
Pulmonary edema
Placental abruption
Neonatal
Stillbirth and neonatal death
Intraventricular hemorrhage
Neonatal infectious morbidity
Neonatal noninfectious morbidity
Birth weight
Days in NICU

Full Information

First Posted
April 17, 2001
Last Updated
July 10, 2019
Sponsor
The George Washington University Biostatistics Center
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT00014989
Brief Title
Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)
Acronym
BEAM
Official Title
Randomized Clinical Trial of the Beneficial Effects of Antenatal Magnesium Sulfate (BEAM)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 1997 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The George Washington University Biostatistics Center
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Intraventricular Hemorrhage, Periventricular Leukomalacia, Pulmonary Edema, Abruptio Placentae
Keywords
Preterm delivery, Cerebral palsy, Magnesium sulfate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2136 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
magnesium sulfate
Primary Outcome Measure Information:
Title
Composite outcome of death or moderate to severe cerebral palsy
Secondary Outcome Measure Information:
Title
Maternal
Title
Chorioamnionitis
Title
Endometritis
Title
Other infectious morbidity
Title
Pulmonary edema
Title
Placental abruption
Title
Neonatal
Title
Stillbirth and neonatal death
Title
Intraventricular hemorrhage
Title
Neonatal infectious morbidity
Title
Neonatal noninfectious morbidity
Title
Birth weight
Title
Days in NICU

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dwight Rouse, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Menachem Miodovnik
Organizational Affiliation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Dept of OB/GYN, University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Dept of OB/GYN, Hutzel Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
St. Luke's - Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Forsyth Memorial Hospital, Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
The University Hospital, University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0794
Country
United States
Facility Name
Case Western University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Dept of OB/GYN, Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
MCP Hahnemann University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Dept of OB/GYN Magee Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905-2499
Country
United States
Facility Name
Dept of OB/GYN, Southwestern Medical Center, University of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9032
Country
United States
Facility Name
University of Texas Medical Branch - Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
University of Texas - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
7838646
Citation
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.
Results Reference
background
PubMed Identifier
8946900
Citation
Schendel 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.
Results Reference
background
PubMed Identifier
8423946
Citation
Hallak 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.
Results Reference
background
PubMed Identifier
7761206
Citation
Aziz 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.
Results Reference
background
PubMed Identifier
7838643
Citation
Pinto-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. Erratum In: Pediatrics 2001 Aug;108(2):238.
Results Reference
background
PubMed Identifier
18753646
Citation
Rouse 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.
Results Reference
result
PubMed Identifier
19622997
Citation
Costantine 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.
Results Reference
result
PubMed Identifier
31143877
Citation
Buhimschi 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.
Results Reference
derived
PubMed Identifier
26254839
Citation
Hirtz 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.
Results Reference
derived
PubMed Identifier
20027029
Citation
Twickler 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.
Results Reference
derived
Links:
URL
http://www.bsc.gwu.edu/mfmu/
Description
Click here for more information on the NICHD MFMU Research Network.

Learn more about this trial

Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)

We'll reach out to this number within 24 hrs