MRI Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01128673
Study type	Observational
Source	Vanderbilt University
Contact
Status	Withdrawn
Phase	N/A
Start date	May 2010
Completion date	June 2018

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT02551003` - Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy	Phase 1/Phase 2
Completed	`NCT02683915` - Reno-protective Effect of Brain Cooling in Newborn With Hypoxia
Recruiting	`NCT01962233` - Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Hypoxic Ischemic Encephalopathy	Phase 1
Completed	`NCT01683383` - California Transport Cooling Trial	N/A
Completed	`NCT01471015` - Darbe Administration in Newborns Undergoing Cooling for Encephalopathy	Phase 1/Phase 2
Completed	`NCT01649648` - Autologous Cord Blood Cells for Brain Injury in Term Newborns	Phase 1
Completed	`NCT01481207` - Magnetic Resonance Imaging and Spectroscopy Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy
Withdrawn	`NCT00993564` - Magnetic Resonance Imaging (MRI) Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy (HIE)	N/A
Completed	`NCT00945789` - Erythropoietin in Infants With Hypoxic Ischemic Encephalopathy (HIE)	Phase 1/Phase 2
Completed	`NCT00097097` - Neonatal Resuscitation in Zambia	Phase 3
Recruiting	`NCT02621944` - Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia	Early Phase 1
Not yet recruiting	`NCT02605018` - Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy	Phase 1/Phase 2
Completed	`NCT01732146` - Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy	Phase 3
Completed	`NCT02349672` - Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (Control Levels)
Completed	`NCT02826941` - Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy	Phase 2
Active, not recruiting	`NCT01138176` - Whole Body Cooling Using Phase Changing Material	Phase 1/Phase 2
Recruiting	`NCT02578823` - Targeted Temperature Management After In-Hospital Cardiac Arrest	N/A
Terminated	`NCT01765218` - Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy	Phase 1/Phase 2
Completed	`NCT01241019` - Safety and Efficacy of Topiramate in Neonates With Hypoxic Ischemic Encephalopathy Treated With Hypothermia	Phase 2
Completed	`NCT00620711` - Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms