Magnetic Resonance Imaging (MRI) Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy (HIE)
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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 |
- 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 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (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
|
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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 |
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
Contacts and Locations| United States, Tennessee | |
| Monroe Carell Jr Children's Hosptial at Vanderbilt | |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: | William F Walsh, MD | Vanderbilt University School of Medicine |
More Information
No publications provided
| Responsible Party: | William F Walsh MD Chief of Nurseries Monroe Carell Jr Children's Hospital, Department of Pediatrics Vanderbilt University, Nashville TN 37232 |
| ClinicalTrials.gov Identifier: | NCT00993564 History of Changes |
| Other Study ID Numbers: | 090575 |
| Study First Received: | October 5, 2009 |
| Last Updated: | March 21, 2011 |
| 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 Ischemia Ischemia Brain Damage, Chronic Delirium Encephalitis Hepatic Encephalopathy Neurotoxicity Syndromes Hypoxia-Ischemia, Brain Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes |
Confusion Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Central Nervous System Viral Diseases Virus Diseases Central Nervous System Infections Liver Failure Hepatic Insufficiency Liver Diseases Digestive System Diseases Brain Diseases, Metabolic Metabolic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013