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

This study has been completed.
Sponsor:
Collaborator:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00131859
First received: August 18, 2005
Last updated: August 12, 2009
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention
Brain Injury, Fetus and Neonate
 Procedure: Diffusion-tensor imaging

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Diffusion-Tensor Magnetic Resonance Imaging and the Evaluation of Perinatal Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Diffusion-tensor imaging differences between brain injured cases and controls without brain injury [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Umbilical cord gas results [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Placental pathology [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Electronic fetal monitoring [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Nucleated red blood cells [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: October 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Diffusion-tensor imaging
    Obtain a Diffusion tensor MRI of brain.
    Other Name: No other names applicable.
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.

  Eligibility

Ages Eligible for Study:   23 Weeks to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Neonates < 1500 grams, with suspected brain injury, and with severe metabolic acidosis

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131859

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287-1228
Sponsors and Collaborators
Johns Hopkins University
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Investigators
Principal Investigator: Ernest M Graham, M.D. Johns Hopkins Univ; Dept. of Gyn-Ob
  More Information

No publications provided

Responsible Party: Ernie Graham, M.D., Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00131859     History of Changes
Other Study ID Numbers: 04-08-31-01
Study First Received: August 18, 2005
Last Updated: August 12, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Perinatal brain injury
Diffusion-tensor imaging

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013