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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary: 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).
Sponsor: NICHD Neonatal Research Network

Current Primary Outcome: Incidence of Intraventricular Hemorrhage [ Time Frame: Hospital discharge 120 days of life ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of cerebral palsy [ Time Frame: 18-22 months corrected age ]

Original Secondary Outcome: Same as current

Information By: NICHD Neonatal Research Network

Dates:
Date Received: September 15, 2010
Date Started: July 1996
Date Completion:
Last Updated: June 3, 2015
Last Verified: June 2015