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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00131859
Enrollment
5
Registered
2005-08-19
Start date
2004-10-31
Completion date
2008-12-31
Last updated
2009-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injury, Fetus and Neonate

Keywords

Perinatal brain injury, Diffusion-tensor imaging

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.

Interventions

PROCEDUREDiffusion-tensor imaging

Obtain a Diffusion tensor MRI of brain.

Sponsors

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
CollaboratorOTHER
Johns Hopkins University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
23 Weeks to 18 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Diffusion-tensor imaging differences between brain injured cases and controls without brain injury2 years

Secondary

MeasureTime frame
Umbilical cord gas results2 years
Placental pathology2 years
Electronic fetal monitoring2 years
Nucleated red blood cells2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026