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

This study has been withdrawn prior to enrollment.
(this is an accidentical duplication of 090575Walsh NCT01128673 and I would like to remove)
Sponsor:
Information provided by (Responsible Party):
William Walsh, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00993564
First received: October 5, 2009
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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
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:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2009
Study Completion Date: July 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   up to 5 Days
Genders Eligible for Study:   Both
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

Criteria

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
  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: NCT00993564

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

No publications provided

Responsible Party: William Walsh, Professor of Pediatrics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00993564     History of Changes
Other Study ID Numbers: 090575
Study First Received: October 5, 2009
Last Updated: July 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Therapeutic hypothermia
Head cooling
Hypoxic ischemic encephalopathy
Newborn

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

ClinicalTrials.gov processed this record on October 20, 2014