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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Vanderbilt University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William Walsh, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01128673
First received: May 20, 2010
Last updated: May 28, 2014
Last verified: May 2014
  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
Hypoxic Ischemic Encephalopathy

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 Vanderbilt University:

Primary Outcome Measures:
  • Brain temperature [ Time Frame: Day three of cooling ] [ Designated as safety issue: No ]
    MRI data will be used to estimate regional brain temperature


Secondary Outcome Measures:
  • Brain temperature upon rewarming [ Time Frame: 2 hours after initial MRI ] [ Designated as safety issue: No ]
    Estimate of brain temperature when rewarmed


Estimated Enrollment: 10
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
Body Cooled
Infants undergoing total body cooling for HIE
HIE,Selective Head Cooled
Infants undergoing head cooling for HIE

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

Ages Eligible for Study:   up to 1 Week
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128673

Locations
United States, Tennessee
Monroe Carell Jr Children's Hospital at Vanderbilt Recruiting
Nashville, Tennessee, United States, 37232
Contact: William F Walsh, MD    615-322-0545    bill.walsh@vanderbilt.edu   
Principal Investigator: William F Walsh, MD         
Sub-Investigator: Jason Moore, PhD         
Sponsors and Collaborators
Vanderbilt University
  More Information

No publications provided

Responsible Party: William Walsh, Chief of Nurseries, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01128673     History of Changes
Other Study ID Numbers: 090575Walsh
Study First Received: May 20, 2010
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014