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In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight Infants (MgSO4)

This study has been completed.
National Center for Research Resources (NCRR)
Information provided by:
NICHD Neonatal Research Network Identifier:
First received: September 15, 2010
Last updated: June 3, 2015
Last verified: June 2015
This study examined the effect of magnesium sulfate (MgSO4) exposure on adverse outcome in extremely low birth weight (ELBW) infants. For infants included in the NICHD Neonatal Research Network Generic Database whose mothers were given prenatal MgSO4, data were prospectively collected on maternal/infant conditions and magnesium exposure (including indications, timing and duration of exposure).

Infant, Newborn
Infant, Low Birth Weight
Infant, Small for Gestational Age
Infant, Premature
Intracranial Hemorrhages
Leukomalacia, Periventricular
Cerebral Palsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight (ELBW) Infants

Resource links provided by NLM:

Further study details as provided by NICHD Neonatal Research Network:

Primary Outcome Measures:
  • Incidence of Intraventricular Hemorrhage [ Time Frame: Hospital discharge 120 days of life ]

Secondary Outcome Measures:
  • Incidence of cerebral palsy [ Time Frame: 18-22 months corrected age ]

Enrollment: 1339
Study Start Date: July 1996
Study Completion Date: June 2000
Primary Completion Date: June 1998 (Final data collection date for primary outcome measure)
Detailed Description:
Retrospective studies suggested that the risk of cerebral palsy and intraventricular hemorrhage (IVH) in extremely premature infants of mothers given magnesium sulfate (MgSO4) may be reduced. The purpose of this study was to examine the effects of MgSO4 exposure on adverse outcomes in extremely low birth weight (ELBW) infants. For infants included in the NICHD Neonatal Research Network Generic Database, data were prospectively collected on maternal/infant conditions and MgSO4 exposure (including indications, timing and duration of exposure).

Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All infants with birth weights 401 through 1500 grams admitted to the NICU within 14 days of age are eligible for the study. In addition, all inborn, liveborn infants in the same weight range (401-1500 gms) who die prior to admission to the NICU are enrolled posthumously.

Inclusion Criteria:

  • Infants born in NRN Centers with a birth weight of 401-1,500g

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01203501

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
Stanford University
Palo Alto, California, United States, 94304
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06504
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20052
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Harvard University
Cambridge, Massachusetts, United States, 02138
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, Ohio
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45267
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Rhode Island
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States, 38163
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
NICHD Neonatal Research Network
National Center for Research Resources (NCRR)
Study Director: James A. Lemons, MD Indiana University
Principal Investigator: Waldemar A. Carlo, MD University of Alabama at Birmingham
Principal Investigator: William Oh, MD Brown University, Womens and Infants Hospital
Principal Investigator: Avroy A. Fanaroff, MD Case Western Reserve University, Rainbow Babies & Children's Hospital
Principal Investigator: Edward F. Donovan, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Barbara J. Stoll, MD Emory University
Principal Investigator: Ann R. Stark, MD Brigham and Women's Hospital
Principal Investigator: Charles R. Bauer, MD University of Miami
Principal Investigator: Lu-Ann Papile, MD University of New Mexico
Principal Investigator: David K. Stevenson, MD Stanford University
Principal Investigator: Sheldon B. Korones, MD University of Tennessee
Principal Investigator: Jon E. Tyson, MD MPH University of Texas Southwestern Medical Center
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: Richard A. Ehrenkranz, MD Yale University
Principal Investigator: Raymond Bain, PhD George Washington University
  More Information

Additional Information:
Responsible Party: James A. Lemons, Lead Principal Investigator, Indiana University Identifier: NCT01203501     History of Changes
Other Study ID Numbers: NICHD-NRN-0016  U10HD034216  U10HD027904  U10HD021364  M01RR000080  U10HD027853  M01RR008084  U10HD027851  M01RR000039  U10HD034167  M01RR001032  M01RR002635  U10HD027856  M01RR000750  U10HD021397  U10HD027881  M01RR000997  U10HD027880  M01RR000070  U10HD021415  U10HD021373  M01RR000633  U10HD021385  U10HD027871  M01RR006022 
Study First Received: September 15, 2010
Last Updated: June 3, 2015

Keywords provided by NICHD Neonatal Research Network:
NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Antenatal Magnesium sulfate

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Body Weight
Cerebral Palsy
Birth Weight
Intracranial Hemorrhages
Leukomalacia, Periventricular
Signs and Symptoms
Pathologic Processes
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Magnesium Sulfate
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators processed this record on February 20, 2017