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MRI Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy(HIE)

This study has been withdrawn prior to enrollment.
(No funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01128673
First Posted: May 24, 2010
Last Update Posted: June 3, 2015
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:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
William Walsh, Vanderbilt University
  Purpose
Hundreds of babies in the world are being treated with brain cooling to prevent brain injury after they lose oxygen at birth. This study will use the newly developed information from the magnet resonance image to determine the actual temperature of the brain. This will enable us to determine if the brain is being uniformly cooled and if techniques that provide cooling need to be changed to improve the injury prevention from cooling.

Condition Intervention
Hypoxic Ischemic Encephalopathy Device: mRI

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: MRI Thermal Imaging of Infants Undergoing Cooling for HIE

Further study details as provided by William Walsh, Vanderbilt University:

Primary Outcome Measures:
  • Brain temperature [ Time Frame: Day three of cooling ]
    MRI data will be used to estimate regional brain temperature


Secondary Outcome Measures:
  • Brain temperature upon rewarming [ Time Frame: 2 hours after initial MRI ]
    Estimate of brain temperature when rewarmed


Enrollment: 0
Study Start Date: May 2010
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Body Cooled
Infants undergoing total body cooling for HIE
Device: mRI
HIE,Selective Head Cooled
Infants undergoing head cooling for HIE
Device: mRI

Detailed Description:

We propose to develop a non-invasive measurement of brain tissue temperature and to apply this measurement of infants under-going cooling for HIE

  1. We propose to do this by refining the use of the MRI evaluation of the NAA-H20 frequency shift. This molecular relationship is quite accurate (based on preliminary studies of an NAA-H20 phantom subject to controlled temperature variations) for measuring relative temperature changes.
  2. The next step will be to perform further phantom imaging with continuous temperature measurements and to expand the phantom model. This work needs funding support to be completed.
  3. At the same time we will be applying the MRI thermal imaging protocol to infants whom have experienced HIE and who are being treated with hypothermia to ameliorate the HIE. We have IRB approval to approach families and to obtain the required data during clinically indicated MRI scans, this data accumulation will add an additional 3-5 minutes to the MRI. We will then perform a second MRI after the infant is rewarmed. We will compare the pairs of readings at two different core temperatures from at least five regions of the brain.
  4. We will evaluate results of regional temperature measurements to determine if cooling of the human infant brain is uniform.
  5. We will compare the two modalities of cooling to determine if selective head cooling and total body cooling provide similar distribution of cooling.
  6. The final goal will be to compare MRI identified injury patterns to the temperature distribution in order to determine if distribution of cooling is related to outcome.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Week   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants with Hypoxic ischemic encephalopathy undergoing cooling
Criteria

Inclusion Criteria:

  • Infants in the NICU who are treated with hypothermia for hypoxic ischemic encephalopathy and who are scheduled to have an MRI for evaluation of the extent of their injury.
  • Parent and attending physician consent to perform evaluation of MRI thermography.

Exclusion Criteria:

  • Infants too unstable to have MRI scan, defined by being on any cardiac pressor medications or more than 40% oxygen on the ventilator.
  • Infants too active to obtain MRI without sedation.
  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): NCT01128673


Locations
United States, Tennessee
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
National Institutes of Health (NIH)
  More Information

Publications:
Magnetic Resonance Thermal Imaging 5th International Conference on Brain Monitoring and Imaging William F. Walsh1, Jason E. Moore3,4, Subechhya Pradhan3,4, Curtis Wuschensky2, J. Christopher Gatenby3,5, E. Brian Welch3,6 1Division of Neonatology, Vanderbilt University Medical Center, Nashville, TN 2Neuroradiology, Vanderbilt University Medical Center, Nashville, TN 3Institute of Imaging Science, Vanderbilt University, Nashville, TN 4Department of Physics and Astronomy, Vanderbilt University, Nashville, TN 5Department of Biomedical Engineering, Vanderbilt University, Nashville, TN 6Philips Healthcare, Cleveland, OH

Responsible Party: William Walsh, Chief of Nurseries, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01128673     History of Changes
Other Study ID Numbers: 090575Walsh
First Submitted: May 20, 2010
First Posted: May 24, 2010
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by William Walsh, Vanderbilt University:
Hypoxic Ischemic encephalopathy
Magnet resonance imaging
Selective Head cooling
Therapeutic hypothermia

Additional relevant MeSH terms:
Ischemia
Brain Diseases
Hypoxia
Brain Ischemia
Hypoxia-Ischemia, Brain
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain