Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)

Cerebral Palsy Clinical Trial

— BEAM  

Official title:

Randomized Clinical Trial of the Beneficial Effects of Antenatal Magnesium Sulfate (BEAM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00014989
• Other study ID #: NICHD-0800
• Secondary ID: U10HD021414U10HD
• Status: Completed
• Phase: Phase 3
• Start date: December 1997
• Est. completion date: June 2007

Study information

• Verified date: July 2019
• Source: The George Washington University Biostatistics Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2136
• Est. completion date: June 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Abruptio Placentae
• Cerebral Hemorrhage
• Cerebral Palsy
• Hemorrhage
• Intraventricular Hemorrhage
• Leukomalacia, Periventricular
• Periventricular Leukomalacia
• Pulmonary Edema

Intervention

Drug:
• magnesium sulfate

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	The University Hospital, University of Cincinnati	Cincinnati	Ohio
United States	Case Western University	Cleveland	Ohio
United States	Dept of OB/GYN, Ohio State University	Columbus	Ohio
United States	Dept of OB/GYN, Southwestern Medical Center, University of Texas	Dallas	Texas
United States	Dept of OB/GYN, Hutzel Hospital	Detroit	Michigan
United States	University of Texas Medical Branch - Galveston	Galveston	Texas
United States	University of Texas - Houston	Houston	Texas
United States	Dept of OB/GYN, University of Miami	Miami	Florida
United States	St. Luke's - Roosevelt Hospital	New York	New York
United States	MCP Hahnemann University	Philadelphia	Pennsylvania
United States	Dept of OB/GYN Magee Womens Hospital	Pittsburgh	Pennsylvania
United States	Women and Infants Hospital	Providence	Rhode Island
United States	University of Utah Medical Center	Salt Lake City	Utah
United States	Forsyth Memorial Hospital, Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
The George Washington University Biostatistics Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

Costantine MM, Weiner SJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Effects of antenatal exposure to magnesium sulfate on neuroprotection and mortality in preterm infants: a meta — View 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. — View 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. — View 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. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite outcome of death or moderate to severe cerebral palsy
Secondary	Maternal
Secondary	Chorioamnionitis
Secondary	Endometritis
Secondary	Other infectious morbidity
Secondary	Pulmonary edema
Secondary	Placental abruption
Secondary	Neonatal
Secondary	Stillbirth and neonatal death
Secondary	Intraventricular hemorrhage
Secondary	Neonatal infectious morbidity
Secondary	Neonatal noninfectious morbidity
Secondary	Birth weight
Secondary	Days in NICU

External Links

•   Click here for more information on the NICHD MFMU Research Network.