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

NCT01128673 | Withdrawn DMC

• 1 other identifier: 090575Walsh
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxic Ischemic Encephalopathy

Keywords

Hypoxic Ischemic encephalopathy; Magnet resonance imaging; Selective Head cooling; Therapeutic hypothermia

Outcome Measures

Primary Outcomes (1)

• Brain temperature

  MRI data will be used to estimate regional brain temperature

  Day three of cooling

Secondary Outcomes (1)

• Brain temperature upon rewarming

  2 hours after initial MRI

Study Arms (2)

Body Cooled

Infants undergoing total body cooling for HIE

Device: mRI

HIE,Selective Head Cooled

Infants undergoing head cooling for HIE

Device: mRI

Interventions

mRI DEVICE

Body Cooled; HIE,Selective Head Cooled

Eligibility Criteria

• Age: Up to 1 Week
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants with Hypoxic ischemic encephalopathy undergoing cooling

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Monroe Carell Jr Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Nurseries

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 24, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

US (1)