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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This study has been withdrawn prior to enrollment.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

October 5, 2009
July 5, 2013
September 2009
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00993564 on ClinicalTrials.gov Archive Site
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Magnetic Resonance Imaging (MRI) Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy (HIE)
MRI Thermal Imaging of Infants Undergoing Cooling for HIE

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Newborn infants who are treated with cooling for the amelioration of hypoxic ischemic encephalopathy

Hypoxic Ischemic Encephalopathy
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  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
up to 5 Days
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00993564
090575
No
William Walsh, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: William F Walsh, MD Vanderbilt University School of Medicine
Vanderbilt University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP