Hypoxic Ischemic EncephalopathyNCT01128673
MRI Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy(HIE)
An observational study of Hypoxic Ischemic Encephalopathy, run by Vanderbilt University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 1 week
- Conditions the study is for
- Hypoxic Ischemic Encephalopathy
- What is being tested?
- mRI
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 week
- All sexes
- No healthy volunteers
- Child
Study population: Infants with Hypoxic ischemic encephalopathy undergoing cooling
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
About this study
Official title: 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.
Read the 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
- 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.
- 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.
- 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.
- We will evaluate results of regional temperature measurements to determine if cooling of the human infant brain is uniform.
- We will compare the two modalities of cooling to determine if selective head cooling and total body cooling provide similar distribution of cooling.
- 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.
- Conditions
- Hypoxic Ischemic Encephalopathy
- Being tested
- mRI
- Keywords
- Hypoxic Ischemic encephalopathy, Magnet resonance imaging, Selective Head cooling, Therapeutic hypothermia
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRIDevice
| Study group | Role | What they receive |
|---|---|---|
| Body Cooled | Infants undergoing total body cooling for HIE Receives: Device: mRI | |
| HIE,Selective Head Cooled | Infants undergoing head cooling for HIE Receives: Device: mRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain temperature
MRI data will be used to estimate regional brain temperature
Measured: Day three of cooling
Secondary outcomes (1)
Brain temperature upon rewarming
Estimate of brain temperature when rewarmed
Measured: 2 hours after initial MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2018 (estimated)
- Study completionJun 2018 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypoxic Ischemic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, William Walsh, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128673
- Sponsor's protocol ID
- 090575Walsh
- Status last verified
- Jun 2015
- First submitted
- 20 May 2010
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Thermal Imaging of Infants Undergoing Cooling for HIE
- ClinicalTrials.gov ID
- NCT01128673
- Acronym / sponsor ID
- 090575Walsh
- Conditions
- Hypoxic Ischemic Encephalopathy
- Keywords
- Hypoxic Ischemic encephalopathy, Magnet resonance imaging, Selective Head cooling, Therapeutic hypothermia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- May 2010
- Primary completion
- May 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
- 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.
- 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.
- We will evaluate results of regional temperature measurements to determine if cooling of the human infant brain is uniform.
- We will compare the two modalities of cooling to determine if selective head cooling and total body cooling provide similar distribution of cooling.
- 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
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body Cooled | – | Device: mRIInfants undergoing total body cooling for HIE |
| HIE,Selective Head Cooled | – | Device: mRIInfants undergoing head cooling for HIE |
Who may qualify
- Ages
- Up to 1 week
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants with Hypoxic ischemic encephalopathy undergoing cooling
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRI | Device | Body Cooled, HIE,Selective Head Cooled |
Primary outcome
Brain temperature
Time frame: Day three of cooling
MRI data will be used to estimate regional brain temperature
1 secondary outcome
Brain temperature upon rewarming
Time frame: 2 hours after initial MRI
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- BackgroundMagnetic 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
Related trials for Hypoxic Ischemic Encephalopathy
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
RecruitingPhase 2/3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxic Ischemic Encephalopathy, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain temperature (time frame: Day three of cooling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01128673, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.