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

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Key information

Conditions

Infant, Newborn Brain Damage, Chronic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Palsy Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Encephalomalacia Female Urogenital Diseases and Pregnancy Complications Hemorrhage Infant, Low Birth Weight Infant, Newborn, Diseases Infant, Premature Infant, Premature, Diseases Infant, Small for Gestational Age Intracranial Hemorrhages Leukomalacia, Periventricular Nervous System Diseases Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Urogenital Diseases Vascular Diseases

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

Primary outcomes

Incidence of Intraventricular Hemorrhage

Time frame: Hospital discharge 120 days of life

Secondary outcomes

Incidence of cerebral palsy

Time frame: 18-22 months corrected age

Sponsors and collaborators

Lead sponsor

NICHD Neonatal Research Network

Network

Collaborators

National Center for Research Resources (NCRR)

Registry information

Official study title

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

Acronym: MgSO4

Important dates

Study start: 1996
Primary completion: 1998
Study completion: 2000
First posted: Sep 16, 2010
Registry last updated: Sep 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed