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

Hypoxic Ischemic Encephalopathy Clinical Trial

Official title:

MRI Thermal Imaging of Infants Undergoing Cooling for HIE

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00993564
• Other study ID #: 090575
• Status: Withdrawn
• Phase: N/A
• First received: October 5, 2009
• Last updated: July 5, 2013
• Start date: September 2009
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Days

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypoxia-Ischemia, Brain
• Hypoxic Ischemic Encephalopathy
• Ischemia

Locations

Country	Name	City	State
United States	Monroe Carell Jr Children's Hosptial at Vanderbilt	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		One day	No