- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01203501
In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight Infants (MgSO4)
September 22, 2017 updated by: NICHD Neonatal Research Network
In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight (ELBW) Infants
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).
Study Overview
Status
Completed
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).
Study Type
Observational
Enrollment (Actual)
1339
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
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California
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Palo Alto, California, United States, 94304
- Stanford University
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Connecticut
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New Haven, Connecticut, United States, 06504
- Yale University
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District of Columbia
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Washington, D.C., District of Columbia, United States, 20052
- George Washington University
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, United States, 30303
- Emory University
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University
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Massachusetts
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Cambridge, Massachusetts, United States, 02138
- Harvard University
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Michigan
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Detroit, Michigan, United States, 48201
- Wayne State University
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- University Of New Mexico
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Ohio
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Cincinnati, Ohio, United States, 45267
- Cincinnati Children's Medical Center
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Cleveland, Ohio, United States, 44106
- Case Western Reserve University, Rainbow Babies and Children's Hospital
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Rhode Island
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Providence, Rhode Island, United States, 02905
- Brown University, Women & Infants Hospital of Rhode Island
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Tennessee
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Memphis, Tennessee, United States, 38163
- University of Tennessee
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Texas
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Dallas, Texas, United States, 75235
- University Of Texas Southwestern Medical Center At Dallas
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 2 weeks (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- Infants born in NRN Centers with a birth weight of 401-1,500g
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Incidence of Intraventricular Hemorrhage
Time Frame: Hospital discharge 120 days of life
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Hospital discharge 120 days of life
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Incidence of cerebral palsy
Time Frame: 18-22 months corrected age
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18-22 months corrected age
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: James A. Lemons, MD, Indiana University
- Principal Investigator: Ann R. Stark, MD, Brigham and Women's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 1996
Primary Completion (ACTUAL)
June 1, 1998
Study Completion (ACTUAL)
June 1, 2000
Study Registration Dates
First Submitted
September 15, 2010
First Submitted That Met QC Criteria
September 15, 2010
First Posted (ESTIMATE)
September 16, 2010
Study Record Updates
Last Update Posted (ACTUAL)
September 26, 2017
Last Update Submitted That Met QC Criteria
September 22, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Brain Damage, Chronic
- Infant, Newborn, Diseases
- Infant, Premature, Diseases
- Encephalomalacia
- Cerebral Palsy
- Hemorrhage
- Body Weight
- Birth Weight
- Intracranial Hemorrhages
- Leukomalacia, Periventricular
Other Study ID Numbers
- NICHD-NRN-0016
- M01RR000633 (U.S. NIH Grant/Contract)
- U10HD021364 (U.S. NIH Grant/Contract)
- U10HD021373 (U.S. NIH Grant/Contract)
- U10HD021385 (U.S. NIH Grant/Contract)
- U10HD027851 (U.S. NIH Grant/Contract)
- U10HD027853 (U.S. NIH Grant/Contract)
- U10HD027856 (U.S. NIH Grant/Contract)
- U10HD027871 (U.S. NIH Grant/Contract)
- U10HD027880 (U.S. NIH Grant/Contract)
- U10HD027904 (U.S. NIH Grant/Contract)
- U10HD034216 (U.S. NIH Grant/Contract)
- U10HD021415 (U.S. NIH Grant/Contract)
- U10HD027881 (U.S. NIH Grant/Contract)
- M01RR008084 (U.S. NIH Grant/Contract)
- M01RR006022 (U.S. NIH Grant/Contract)
- M01RR000750 (U.S. NIH Grant/Contract)
- M01RR000070 (U.S. NIH Grant/Contract)
- M01RR000997 (U.S. NIH Grant/Contract)
- U10HD021397 (U.S. NIH Grant/Contract)
- U10HD034167 (U.S. NIH Grant/Contract)
- M01RR000039 (U.S. NIH Grant/Contract)
- M01RR000080 (U.S. NIH Grant/Contract)
- M01RR001032 (U.S. NIH Grant/Contract)
- M01RR002635 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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