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

Completed

• Conditions: Brain Injury, Fetus and Neonate

• Registration Number: NCT00131859
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-08-18
• Study First Submitted QC: 2005-08-18
• Study First Posted: 2005-08-19
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-12
• Last Update Posted: 2009-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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Exclusion Criteria

• Major congenital malformations
• Chromosomal abnormality

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diffusion-tensor imaging differences between brain injured cases and controls without brain injury	2 years

Secondary Outcome Measures

Name	Time	Method
Umbilical cord gas results	2 years
Placental pathology	2 years
Electronic fetal monitoring	2 years
Nucleated red blood cells	2 years

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States