Trials / Completed
CompletedNCT01203501
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,339 (actual)
- Sponsor
- NICHD Neonatal Research Network · Network
- Sex
- All
- Age
- 14 Days
- Healthy volunteers
- Accepted
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).
Conditions
- Infant, Newborn
- Infant, Low Birth Weight
- Infant, Small for Gestational Age
- Infant, Premature
- Intracranial Hemorrhages
- Leukomalacia, Periventricular
- Cerebral Palsy
Timeline
- Start date
- 1996-07-01
- Primary completion
- 1998-06-01
- Completion
- 2000-06-01
- First posted
- 2010-09-16
- Last updated
- 2017-09-26
Locations
15 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01203501. Inclusion in this directory is not an endorsement.