NCT00065949

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 1987

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1987

Completed
15.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2003

Completed
Last Updated

June 24, 2005

Status Verified

May 1, 2003

First QC Date

August 1, 2003

Last Update Submit

June 23, 2005

Conditions

Brain InjuriesCerebral Palsy

Keywords

Low birthweight infantsMagnesium supplementationIntracranial hemorrhageCystic periventricular leukomalaciaMental retardation

Interventions

magnesium sulfateDRUG

Eligibility Criteria

Age0 Years - 12 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Multiple congenital anomalies
  • Single congenital anomaly of the central nervous system
  • Unlikely to be available for duration of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • Caddell JL, Graziani LJ, Wiswell TE, Hsieh HC, Mansmann HC Jr. The possible role of magnesium in protection of premature infants from neurological syndromes and visual impairments and a review of survival of magnesium-exposed premature infants. Magnes Res. 1999 Sep;12(3):201-16.

    PMID: 10488476BACKGROUND

MeSH Terms

Conditions

Brain InjuriesCerebral PalsyIntracranial HemorrhagesLeukomalacia, PeriventricularIntellectual Disability

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBrain Damage, ChronicCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsEncephalomalaciaInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Thomas E. Wiswell, M.D.

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 1, 2003

First Posted

August 5, 2003

Study Start

August 1, 1987

Study Completion

February 1, 2003

Last Updated

June 24, 2005

Record last verified: 2003-05

Locations

US(1)