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

Sponsor

NICHD Neonatal Research Network (Other)

Overall Status

Completed

CT.gov ID

NCT01203501

Collaborator

National Center for Research Resources (NCRR) (NIH)

1,339

Enrollment

Locations

Duration (Months)

89.3

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Intracranial Hemorrhages Leukomalacia, Periventricular Cerebral Palsy

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 Design

Study Type:

Observational

Actual Enrollment :

1339 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 1996

Actual Primary Completion Date :

Jun 1, 1998

Actual Study Completion Date :

Jun 1, 2000

Outcome Measures

Primary Outcome Measures

Incidence of Intraventricular Hemorrhage [Hospital discharge 120 days of life]

Secondary Outcome Measures

Incidence of cerebral palsy [18-22 months corrected age]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 14 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	Stanford University	Palo Alto	California	United States	94304
3	Yale University	New Haven	Connecticut	United States	06504
4	George Washington University	Washington, D.C.	District of Columbia	United States	20052
5	University of Miami	Miami	Florida	United States	33136
6	Emory University	Atlanta	Georgia	United States	30303
7	Indiana University	Indianapolis	Indiana	United States	46202
8	Harvard University	Cambridge	Massachusetts	United States	02138
9	Wayne State University	Detroit	Michigan	United States	48201
10	University of New Mexico	Albuquerque	New Mexico	United States	87131
11	Cincinnati Children's Medical Center	Cincinnati	Ohio	United States	45267
12	Case Western Reserve University, Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106
13	Brown University, Women & Infants Hospital of Rhode Island	Providence	Rhode Island	United States	02905
14	University of Tennessee	Memphis	Tennessee	United States	38163
15	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas	United States	75235

Sponsors and Collaborators

NICHD Neonatal Research Network
National Center for Research Resources (NCRR)

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