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

This study has been terminated.

(this is an accidentical duplication of 090575Walsh NCT01128673 and I would like to remove)

Sponsor:

Information provided by:

Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00993564

First received: October 5, 2009

Last updated: March 21, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 5, 2009

Last Updated Date

March 21, 2011

Start Date ^ICMJE

September 2009

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00993564 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

MRI Thermal Imaging of Infants Undergoing Cooling for HIE

Brief 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.

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Newborn infants who are treated with cooling for the amelioration of hypoxic ischemic encephalopathy

Condition ^ICMJE

Hypoxic Ischemic Encephalopathy

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Selective head cooled infants cooled
Infants with HIE who have undergone head cooling for the amelioration of HIE
Selective head cooled infants rewarmed
Same infants after rewarming

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Estimated Completion Date

December 2011

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 5 Days

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00993564

Other Study ID Numbers ^ICMJE

090575

Has Data Monitoring Committee

Responsible Party

William F Walsh MD Chief of Nurseries Monroe Carell Jr Children's Hospital, Department of Pediatrics Vanderbilt University, Nashville TN 37232

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

William F Walsh, MD

Vanderbilt University School of Medicine

Information Provided By

Vanderbilt University

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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