In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight Infants
MgSO4
MgSO4
Sponsor study identifier
Secondary identifiers
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
observational
1,339
1 country
15
Study Start
July 1996
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 1998
Actual (reported)Study Completion
June 2000
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2000
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1996
Date type not reportedThis date has not been verified as actual or estimated.
June 1998
Actual (reported)June 2000
Actual (reported)September 15, 2010
Actual (reported)September 16, 2010
Actual (reported)Incidence of Intraventricular Hemorrhage
Hospital discharge 120 days of life
Incidence of cerebral palsy
18-22 months corrected age
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.
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Stanford University
Palo Alto, California, 94304, United States
Yale University
New Haven, Connecticut, 06504, United States
George Washington University
Washington D.C., District of Columbia, 20052, United States
University of Miami
Miami, Florida, 33136, United States
Emory University
Atlanta, Georgia, 30303, United States
Indiana University
Indianapolis, Indiana, 46202, United States
James A. Lemons, MD
Indiana University
Waldemar A. Carlo, MD
University of Alabama at Birmingham
William Oh, MD
Brown University, Womens and Infants Hospital
Avroy A. Fanaroff, MD
Case Western Reserve University, Rainbow Babies & Children's Hospital
1,339 participants (actual enrollment reported by the registry).
First Submitted
September 15, 2010
First Posted
September 16, 2010
Study Start
July 1996
Date type not reportedThis date has not been verified as actual or estimated.
Generic Database of Very Low Birth Weight Infants
Contact the study team to confirm eligibility.
Harvard University
Cambridge, Massachusetts, 02138, United States
Wayne State University
Detroit, Michigan, 48201, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
University of Tennessee
Memphis, Tennessee, 38163, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
Edward F. Donovan, MD
Children's Hospital Medical Center, Cincinnati
Barbara J. Stoll, MD
Emory University
Ann R. Stark, MD
Brigham and Women's Hospital
Charles R. Bauer, MD
University of Miami
Lu-Ann Papile, MD
University of New Mexico
David K. Stevenson, MD
Stanford University
Sheldon B. Korones, MD
University of Tennessee
Jon E. Tyson, MD MPH
University of Texas Southwestern Medical Center
Seetha Shankaran, MD
Wayne State University
Richard A. Ehrenkranz, MD
Yale University
Raymond Bain, PhD
George Washington University
Primary Completion
June 1998
Actual (reported)Study Completion
June 2000
Actual (reported)Last Updated
September 26, 2017
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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