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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1339 participants

Study Classification

OBSERVATIONAL

Study Start Date

1996-07-31

Study Completion Date

2000-06-30

Brief Summary

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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).

Detailed Description

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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).

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Indiana University

Principal Investigators

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James A. Lemons, MD

Role: STUDY_DIRECTOR

Indiana University

Waldemar A. Carlo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

William Oh, MD

Role: PRINCIPAL_INVESTIGATOR

Brown University, Womens and Infants Hospital

Avroy A. Fanaroff, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University, Rainbow Babies & Children's Hospital

Edward F. Donovan, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Barbara J. Stoll, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Ann R. Stark, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Charles R. Bauer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Lu-Ann Papile, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

David K. Stevenson, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Sheldon B. Korones, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Jon E. Tyson, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Seetha Shankaran, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Richard A. Ehrenkranz, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Raymond Bain, PhD

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Stanford University

Palo Alto, California, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

George Washington University

Washington D.C., District of Columbia, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

Harvard University

Cambridge, Massachusetts, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Site Status

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Site Status

University of Tennessee

Memphis, Tennessee, United States

Site Status

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

Countries

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United States