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

Brain Injury, Fetus and Neonate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131859
• Other study ID #: 04-08-31-01
• Status: Completed
• Phase: N/A
• First received: August 18, 2005
• Last updated: August 12, 2009
• Start date: October 2004
• Est. completion date: December 2008

Study information

• Verified date: August 2009
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 23 Weeks to 18 Months

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury, Fetus and Neonate

Intervention

Procedure:
• Diffusion-tensor imaging
Obtain a Diffusion tensor MRI of brain.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diffusion-tensor imaging differences between brain injured cases and controls without brain injury		2 years	No
Secondary	Umbilical cord gas results		2 years	No
Secondary	Placental pathology		2 years	No
Secondary	Electronic fetal monitoring		2 years	No
Secondary	Nucleated red blood cells		2 years	No