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NCT01203501 Clinical Trial

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

Cerebral Palsy Clinical Trial

— MgSO4  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01203501
Other study ID # NICHD-NRN-0016
Secondary ID U10HD034216U10HD
Status Completed
Phase N/A
First received September 15, 2010
Last updated September 22, 2017
Start date July 1996
Est. completion date June 2000

Study information
Verified date September 2017
Source NICHD Neonatal Research Network
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

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).

Recruitment information / eligibility
Status Completed
Enrollment 1339
Est. completion date June 2000
Est. primary completion date June 1998
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 14 Days
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of New Mexico Albuquerque New Mexico
United States Emory University Atlanta Georgia
United States University of Alabama at Birmingham Birmingham Alabama
United States Harvard University Cambridge Massachusetts
United States Cincinnati Children's Medical Center Cincinnati Ohio
United States Case Western Reserve University, Rainbow Babies and Children's Hospital Cleveland Ohio
United States University of Texas Southwestern Medical Center at Dallas Dallas Texas
United States Wayne State University Detroit Michigan
United States Indiana University Indianapolis Indiana
United States University of Tennessee Memphis Tennessee
United States University of Miami Miami Florida
United States Yale University New Haven Connecticut
United States Stanford University Palo Alto California
United States Brown University, Women & Infants Hospital of Rhode Island Providence Rhode Island
United States George Washington University Washington, D.C. District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
NICHD Neonatal Research Network National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Intraventricular Hemorrhage Hospital discharge 120 days of life
Secondary Incidence of cerebral palsy 18-22 months corrected age
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