MRI Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy(HIE)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Vanderbilt University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Vanderbilt University
Collaborator:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01128673
First received: May 20, 2010
Last updated: March 21, 2011
Last verified: March 2011
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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: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (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
- 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.
- 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.
- 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.
- We will evaluate results of regional temperature measurements to determine if cooling of the human infant brain is uniform.
- We will compare the two modalities of cooling to determine if selective head cooling and total body cooling provide similar distribution of cooling.
- 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
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 F Walsh MD Chief of Nurseries Monroe Carell Jr Children's Hospital, Department of Pediatrics Vanderbilt University, Nashville TN 37232 |
| ClinicalTrials.gov Identifier: | NCT01128673 History of Changes |
| Other Study ID Numbers: | 090575Walsh |
| Study First Received: | May 20, 2010 |
| Last Updated: | March 21, 2011 |
| 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:
|
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 June 18, 2013