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Magnesium Sulfate to Prevent Brain Injury in Premature Infants

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Active, not recruiting
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Identifier:
First received: August 1, 2003
Last updated: June 23, 2005
Last verified: May 2003
Premature infants are at risk for acute brain injuries and long-term developmental problems such as cerebral palsy (CP). Research suggests that high levels of magnesium at and around the time of birth may decrease the risk of brain injuries. This study will evaluate the effects of giving magnesium to premature infants.

Condition Intervention Phase
Brain Injuries
Cerebral Palsy
Drug: magnesium sulfate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Magnesium Prevention of Brain Injury in Preterm Infants

Resource links provided by NLM:

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Study Start Date: August 1987
Estimated Study Completion Date: February 2003
Detailed Description:

Premature infants weighing less than 1500 grams (3.3 lbs) represent approximately 1.3% of liveborn infants, yet comprise at least 25% of all children who are subsequently diagnosed with CP. Antepartum exposure to magnesium (Mg) may prevent or ameliorate early brain injury (intracranial hemorrhage and cystic periventricular leukomalacia), as well as long-term adverse neurodevelopmental outcomes (CP and mental retardation) in very low birthweight (VLBW) preterm infants. In preliminary studies, short- and long-term neuroprotection were associated with initial serum Mg levels above 3.0 mEq/L. This study will determine whether early abnormal neurosonographic findings and long-term adverse neurodevelopmental outcomes in VLBW premature infants are influenced by different levels of serum Mg achieved during the first week of life.

Infants will be randomized to either "standard" Mg therapy or "high" Mg therapy. Standard Mg therapy consists of no supplemental Mg for the first 3 days of life followed by intravenous magnesium sulfate (MgSO4) aimed at attaining serum Mg levels in the normal range of 1.2-2.3 mEq/L. High Mg therapy consists of using intravenous MgSO4 to maintain higher (nonharmful) serum Mg levels between 3.5-5.5 mEq/L for the first 3 days of life and between 2.5-3.5 mEq/L for the next 4 days. The high Mg infants will subsequently have their serum Mg levels maintained at 2.4+0.3 mEq/L using oral magnesium gluconate for the remainder of their neonatal hospitalization.

Infants will be evaluated for early brain injury with head ultrasound studies 12 to 24 hours after birth, at 2 to 3 day intervals while ventilator support is required, and at weekly intervals until discharge. The infants will subsequently be assessed in the high-risk follow-up clinic for a minimum of 24 months (corrected for degree of prematurity). At 24 months of age, they will be evaluated by a pediatric neurologist for the presence of cerebral palsy. They will be tested serially for problems in early cognition (mental, language, and perceptual ability), as well as fine and gross motor skills.


Ages Eligible for Study:   up to 12 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Born at 23 to 32 weeks’ gestation
  • Weighs 500 to 1500 grams (1.1 to 3.3 lbs)
  • Requires mechanical ventilation
  • Less than 12 hours of age at time of enrollment

Exclusion Criteria

  • Multiple congenital anomalies
  • Single congenital anomaly of the central nervous system
  • Unlikely to be available for duration of the study
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Please refer to this study by its identifier: NCT00065949

United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Thomas E. Wiswell, M.D. Thomas Jefferson University
  More Information

Publications: Identifier: NCT00065949     History of Changes
Other Study ID Numbers: HD21453
5R01HD021453 ( US NIH Grant/Contract Award Number )
Study First Received: August 1, 2003
Last Updated: June 23, 2005

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Low birthweight infants
Magnesium supplementation
Intracranial hemorrhage
Cystic periventricular leukomalacia
Mental retardation

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Cerebral Palsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Damage, Chronic
Magnesium Sulfate
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents processed this record on May 22, 2017