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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01203501
First received: September 15, 2010
Last updated: January 9, 2011
Last verified: September 2010
  Purpose

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).


Condition
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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Incidence of Intraventricular Hemorrhage [ Time Frame: Hospital discharge 120 days of life ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of cerebral palsy [ Time Frame: 18-22 months corrected age ] [ Designated as safety issue: Yes ]

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).

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  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 ClinicalTrials.gov identifier: NCT01203501

Locations
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
Investigators
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:
No publications provided

Responsible Party: James A. Lemons, Lead Principal Investigator, Indiana University
ClinicalTrials.gov 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: January 9, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Prematurity
Antenatal Magnesium sulfate

Additional relevant MeSH terms:
Birth Weight
Body Weight
Cerebral Palsy
Hemorrhage
Intracranial Hemorrhages
Leukomalacia, Periventricular
Brain Damage, Chronic
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Encephalomalacia
Infant, Newborn, Diseases
Infant, Premature, Diseases
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Magnesium Sulfate
Analgesics
Anesthetics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 19, 2014