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

MRI Thermal Imaging of Infants Undergoing Cooling for HIE

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypoxic Ischemic Encephalopathy
• Intervention / Treatment: Device: mRI

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

1. 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.
2. 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.
3. 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.
4. We will evaluate results of regional temperature measurements to determine if cooling of the human infant brain is uniform.
5. We will compare the two modalities of cooling to determine if selective head cooling and total body cooling provide similar distribution of cooling.
6. 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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Monroe Carell Jr Children's Hospital at Vanderbilt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Infants with Hypoxic ischemic encephalopathy undergoing cooling

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Body Cooled; Infants undergoing total body cooling for HIE	Device: mRI
HIE,Selective Head Cooled; Infants undergoing head cooling for HIE	Device: mRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain temperature	MRI data will be used to estimate regional brain temperature	Day three of cooling

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain temperature upon rewarming	Estimate of brain temperature when rewarmed	2 hours after initial MRI

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: National Institutes of Health (NIH)

Publications and helpful links

General Publications

• Magnetic Resonance Thermal Imaging 5th International Conference on Brain Monitoring and Imaging William F. Walsh1, Jason E. Moore3,4, Subechhya Pradhan3,4, Curtis Wuschensky2, J. Christopher Gatenby3,5, E. Brian Welch3,6 1Division of Neonatology, Vanderbilt University Medical Center, Nashville, TN 2Neuroradiology, Vanderbilt University Medical Center, Nashville, TN 3Institute of Imaging Science, Vanderbilt University, Nashville, TN 4Department of Physics and Astronomy, Vanderbilt University, Nashville, TN 5Department of Biomedical Engineering, Vanderbilt University, Nashville, TN 6Philips Healthcare, Cleveland, OH

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ANTICIPATED): May 1, 2018
• Study Completion (ANTICIPATED): June 1, 2018

Study Registration Dates

• First Submitted: May 20, 2010
• First Submitted That Met QC Criteria: May 21, 2010
• First Posted (ESTIMATE): May 24, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 3, 2015
• Last Update Submitted That Met QC Criteria: June 1, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Therapeutic hypothermia; Hypoxic Ischemic encephalopathy; Magnet resonance imaging; Selective Head cooling
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Hypoxia, Brain; Brain Ischemia; Ischemia; Brain Diseases; Hypoxia; Hypoxia-Ischemia, Brain
• Other Study ID Numbers: 090575Walsh