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

Completed

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

• Registration Number: NCT01203501
• Lead Sponsor: NICHD Neonatal Research Network

Brief 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).

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 Timeline

• Study Start: 1996-07
• Primary Completion: 1998-06
• Study Completion: 2000-06
• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-22
• Last Update Posted: 2017-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1339

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Intraventricular Hemorrhage	Hospital discharge 120 days of life

Secondary Outcome Measures

Name	Time	Method
Incidence of cerebral palsy	18-22 months corrected age

Trial Locations

Locations (15)

University of Miami; 🇺🇸 Miami, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Texas Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

George Washington University; 🇺🇸 Washington, D.C., District of Columbia, United States

Cincinnati Children's Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Brown University, Women & Infants Hospital of Rhode Island; 🇺🇸 Providence, Rhode Island, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Harvard University; 🇺🇸 Cambridge, Massachusetts, United States

University of Tennessee; 🇺🇸 Memphis, Tennessee, United States

Case Western Reserve University, Rainbow Babies and Children's Hospital; 🇺🇸 Cleveland, Ohio, United States