AzTrials
AzTrials

Cerebral PalsyPhase 3BEAMNCT00014989

Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)

A Phase 3 study testing magnesium sulfate in people with Cerebral Palsy and Intraventricular Hemorrhage, run by The George Washington University Biostatistics Center at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Any age, women only
What is being tested?
magnesium sulfate
How many people
2,136 participants
Where
17 sitesUnited States
Study dates
Dec 1997to Jun 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Maternal medical complications contraindicating magnesium sulfate treatment
  • Participation in any intervention study which influences infant neurological outcome
  • Previous participation in this trial

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • University of Alabama

    Birmingham, Alabama, 35233

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Northwestern University

    Chicago, Illinois, 60611

  • The University Hospital, University of Cincinnati

    Cincinnati, Ohio, 45267-0794

  • Case Western University

    Cleveland, Ohio, 44109

  • Dept of OB/GYN, Ohio State University

    Columbus, Ohio, 43210

  • Dept of OB/GYN, Southwestern Medical Center, University of Texas

    Dallas, Texas, 75235-9032

  • Dept of OB/GYN, Hutzel Hospital

    Detroit, Michigan, 48201

  • University of Texas Medical Branch - Galveston

    Galveston, Texas, 77555

  • University of Texas - Houston

    Houston, Texas, 77030

  • Dept of OB/GYN, University of Miami

    Miami, Florida, 33136

  • St. Luke's - Roosevelt Hospital

    New York, New York, 10019

  • MCP Hahnemann University

    Philadelphia, Pennsylvania, 19102

  • Dept of OB/GYN Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Women and Infants Hospital

    Providence, Rhode Island, 02905-2499

  • University of Utah Medical Center

    Salt Lake City, Utah, 84132

  • Forsyth Memorial Hospital, Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
magnesium sulfate
Keywords
Preterm delivery, Cerebral palsy, Magnesium sulfate
Medical subject headings
Cerebral Palsy, Leukomalacia, Periventricular, Pulmonary Edema, Abruptio Placentae, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • magnesium sulfateDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite outcome of death or moderate to severe cerebral palsy

Secondary outcomes (13)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2001 (estimated)
  2. Study startDec 1997
  3. Primary completionFeb 2007
  4. Study completionJun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
2,136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00014989
Sponsor's protocol ID
NICHD-0800
Other IDs
U10HD021414, U10HD021410, U10HD027905, U10HD027917, U10HD027860, U10HD027915, U10HD034116, U10HD034208
Acronym
BEAM
Status last verified
Jul 2019
First submitted
17 Apr 2001
Last updated
12 Jul 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 7838646

  • 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.

    PubMed 8946900

  • 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.

    PubMed 8423946

  • 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.

    PubMed 7761206

  • 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.

    PubMed 7838643

  • 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.

    PubMed 18753646

  • 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.

    PubMed 19622997

  • 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.

    PubMed 31143877

  • 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.

    PubMed 26254839

  • 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.

    PubMed 20027029

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing magnesium sulfate in people with Cerebral Palsy and Intraventricular Hemorrhage, run by The George Washington University Biostatistics Center at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite outcome of death or moderate to severe cerebral palsy. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00014989, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in