Diffusion-Tensor Magnetic Resonance Imaging (MRI) and the Evaluation of Perinatal Brain Injury

NCT ID: NCT00131859

Last Updated: 2009-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-31

Study Completion Date

2008-12-31

Brief Summary

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The researchers' objective is to use diffusion-tensor imaging (DTI) to evaluate infants diagnosed with cerebral white matter injury during the neonatal period and identify antenatal risk factors, electronic fetal heart rate monitoring abnormalities, and umbilical arterial gas results that are associated with cerebral white matter injury. The researchers' hypothesis is that this new imaging technique will help us better understand how these devastating injuries occur.

Detailed Description

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Maternal and neonatal data will be collected as well as the umbilical arterial gas results and the electronic fetal heart rate tracing of the labor. Infants will have a head ultrasound at 24-72 hours, 10-14 days, and at 4-6 weeks to look for cerebral white matter injury, as standard of care. All infants with a birth weight \< 1500 grams will be offered DTI, and infants \> 1500 grams with white matter injury diagnosed by ultrasound will be imaged as well as the subsequent delivery born within 7 days of that gestational age without brain injury. All infants will have the DTI brain scan at 12-18 months of age corrected for the degree of prematurity, and will also have a formal neurological assessment at that time.

Conditions

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Brain Injury, Fetus and Neonate

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Diffusion-tensor imaging

Obtain a Diffusion tensor MRI of brain.

Intervention Type PROCEDURE

Other Intervention Names

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No other names applicable.

Eligibility Criteria

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Inclusion Criteria

* All infants born at our hospital at \< 1500 grams
* All infants born at our hospital at \> 1500 grams with brain injury or severe metabolic acidosis

Exclusion Criteria

* Major congenital malformations
* Chromosomal abnormality
Minimum Eligible Age

23 Weeks

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Johns Hopkins University School of Medicine

Principal Investigators

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Ernest M Graham, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Univ; Dept. of Gyn-Ob

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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04-08-31-01

Identifier Type: -

Identifier Source: org_study_id

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