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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00131859
First Posted: August 19, 2005
Last Update Posted: August 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Information provided by:
Johns Hopkins University
  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:


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 ]

Secondary Outcome Measures:
  • Umbilical cord gas results [ Time Frame: 2 years ]
  • Placental pathology [ Time Frame: 2 years ]
  • Electronic fetal monitoring [ Time Frame: 2 years ]
  • Nucleated red blood cells [ Time Frame: 2 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 18 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131859


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287-1228
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
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

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
First Submitted: August 18, 2005
First Posted: August 19, 2005
Last Update Posted: August 13, 2009
Last Verified: August 2009

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

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