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

This study has been completed.
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
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
History of Changes

September 15, 2010
January 9, 2011
July 1996
June 1998   (final data collection date for primary outcome measure)
Incidence of Intraventricular Hemorrhage [ Time Frame: Hospital discharge 120 days of life ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01203501 on ClinicalTrials.gov Archive Site
Incidence of cerebral palsy [ Time Frame: 18-22 months corrected age ] [ Designated as safety issue: Yes ]
Same as current
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In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight Infants
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).

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).
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.
  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature
  • Intracranial Hemorrhages
  • Leukomalacia, Periventricular
  • Cerebral Palsy
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1339
June 2000
June 1998   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Both
up to 14 Days
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01203501
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
No
James A. Lemons, Lead Principal Investigator, Indiana University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Research Resources (NCRR)
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP