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

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. Identifier: NCT00993564
Recruitment Status : Withdrawn (this is an accidentical duplication of 090575Walsh NCT01128673 and I would like to remove)
First Posted : October 12, 2009
Last Update Posted : July 9, 2013
Information provided by (Responsible Party):
William Walsh, Vanderbilt University

Brief Summary:
The investigators will determine if the MRI can be used to determine the temperature inside the brain. This is an important piece of information now that cooling the brain is being used to decrease brain damage in infants who had a decrease in brain oxygen or flow around the time of birth.

Condition or disease
Hypoxic Ischemic Encephalopathy

Detailed Description:
There are presently two modes of providing cooling for the infant with HIE: 1) systemic cooling of the entire body (Body Cooling) to 33.5°C documented by rectal temperature and 2) selective head cooling via an FDA approved Cool-cap device which cools the rectal temperature to 34.5°C by applying a continuous flow of very cold (10°C) water to the scalp. The potential advantage of the latter approach lies in the brain being selectively cooled relative to the rectal temperature. Experimental direct temperature measurements in animals have shown that both methods cool the brain; however, despite FDA approval and world-wide application, no one has ever demonstrated that the brain of a human can be cooled effectively, and it is further not known if the cooling is uniform. Most investigators assume the surface will be cooled to a greater degree than the deep brain structures, especially with selective head cooling.We will use a modification of the information obtained from the MRI to determine the distribution of temperatures within the infants brain.

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: MRI Thermal Imaging of Infants Undergoing Cooling for HIE
Study Start Date : September 2009
Estimated Primary Completion Date : December 2012
Actual Study Completion Date : July 2013

Selective head cooled infants cooled
Infants with HIE who have undergone head cooling for the amelioration of HIE
Selective head cooled infants rewarmed
Same infants after rewarming

Primary Outcome Measures :
  1. We will determine if the MRI temperature measurement protocol gives different distributions of temperature within the brain of infants undergoing cooling and the same infant rewarmed. [ Time Frame: One day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newborn infants who are treated with cooling for the amelioration of hypoxic ischemic encephalopathy

Inclusion Criteria:

  • Diagnosis of HIE and candidate for cooling
  • Stable enough to undergo MRI scan while cooled
  • Quiet enough to undergo MRI scan without further sedation
  • Parent informed consent

Exclusion Criteria:

  • Infant too unstable to undergo MRI scan
  • Infant too active to undergo MRI scan

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 identifier (NCT number): NCT00993564

United States, Tennessee
Monroe Carell Jr Children's Hosptial at Vanderbilt
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: William F Walsh, MD Vanderbilt University School of Medicine

Responsible Party: William Walsh, Professor of Pediatrics, Vanderbilt University Identifier: NCT00993564     History of Changes
Other Study ID Numbers: 090575
First Posted: October 12, 2009    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: July 2013

Keywords provided by William Walsh, Vanderbilt University:
Therapeutic hypothermia
Head cooling
Hypoxic ischemic encephalopathy

Additional relevant MeSH terms:
Brain Diseases
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