Hypoxic-Ischemic EncephalopathyNCT03079492
MRI of Neonate With HIE Before and During the Moderate Hypothermia
An observational study of Hypoxic-Ischemic Encephalopathy, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Moderate hypothermia has been demonstrated to be the effective treatment for neonates with hypoxic-ischemic encephalopathy (HIE). However, few studies reveal the actual alterations in physiological parameters (i.e. brain temperature and cerebral blood flow) of neonates undergoing cooling, especially for HIE lesions. Read more about this study
- Who is it for?
- Ages 6 hours to 4 days
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy
- What is being tested?
- Magnetic resonance imaging
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 31 May 2020
- How long will I take part?
- 2 Days
- 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 6 hours to 4 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates with hypoxic-ischemic encephalopathy who fulfill the moderate hypothermia criteria
Who may be able to join
- Neonates in the neonatal intensive care unit who fulfill the hypothermia criteria for treating the hypoxic ischemic encephalopathy and who are scheduled to have an MRI for evaluation of the extent of their injury.
- Parents, clinicians and physician consent to perform evaluation of MRI before and during the hypothermia.
Who cannot join
- Neonates too unstable to have MRI exam, defined by being more than 40% oxygen on the ventilator.
- Hypothermia treatment interruption caused by potential factors.
- Neonates with central nervous system infection,intracranial hemorrhage and brain parenchyma lesions caused by trauma.
Trial locations and contacts
1 site in 1 country.
Chao Jin, Phd contact
China1 site
the First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Chao Jin, Phd, jinny.369@163.com
About this study
Official title: Magnetic Resonance Imaging of Neonates With Hypoxic Ischemic Encephalopathy Before and During Moderate Hypothermia
Moderate hypothermia has been demonstrated to be the effective treatment for neonates with hypoxic-ischemic encephalopathy (HIE). However, few studies reveal the actual alterations in physiological parameters (i.e. brain temperature and cerebral blood flow) of neonates undergoing cooling, especially for HIE lesions. Therefore, this project aims to utilize the magnetic resonance imaging (MRI), i.e. MR thermal imaging and phase contrast MRI to measure the changes of these parameters before and during hypothermia; and then make comparisons with the routine nasopharyngeal and rectal temperature. All these would provide in vivo quantitative data for therapeutic evaluation and promote the optimization.
Read the detailed description
- Study objects 1.1 Primary object To examine the changes of brain temperature and cerebral blood flow in neonates with HIE before and during (i.e. cooling lasting for 24~36 hr) selective brain cooling. 1.2 Secondary object To compare the differences in temperature between brain (thalamus and HIE lesions) and nasopharynx and rectum of HIE neonates during the cooling.
- Methods Prospective observational study; the MR thermal imaging and phase contrast MRI will be used to estimate brain temperature and cerebral blood flow.
Neonates with HIE who fulfilled the moderate hypothermia criteria will be recruited from the neonatal intensive care units. MR scans will be performed twice after informed parental consent. The first scan will be before the hypothermia and the second scan will be during the hypothermia. The first scan will be performed while the neonate is still in the intensive care unit. At the time of the second MR scan, the neonate is still in the intensive care unit, and the neonate in hypothermia group is receiving the brain selective cooling. Sedation would be used if required in these babies.
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Being tested
- Magnetic resonance imaging
- 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.
Magnetic resonance imagingDevice
Magnetic resonance imaging will be used to estimate brain temperature and cerebral blood flow
What is being measured
The primary outcome is the main question the study is designed to answer.
Cooling-induced changes in brain temperature and cerebral blood flow
Magnetic resonance imaging will be used to measure the changes of brain temperature and cerebral blood flow before and during the brain selective cooling
Measured: before and during (cooling lasting for 24~36 hr) the hypothermia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start1 Jun 2017 (estimated)
- Primary completion31 May 2019 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao Jin, Phd, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079492
- Sponsor's protocol ID
- 2016YFC0100300HIE01
- Status last verified
- Feb 2017
- First submitted
- 8 Mar 2017
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging of Neonates With Hypoxic Ischemic Encephalopathy Before and During Moderate Hypothermia
- ClinicalTrials.gov ID
- NCT03079492
- Acronym / sponsor ID
- 2016YFC0100300HIE01
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 14 Mar 2017 (actual)
- 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.
Moderate hypothermia has been demonstrated to be the effective treatment for neonates with hypoxic-ischemic encephalopathy (HIE). However, few studies reveal the actual alterations in physiological parameters (i.e. brain temperature and cerebral blood flow) of neonates undergoing cooling, especially for HIE lesions. Therefore, this project aims to utilize the magnetic resonance imaging (MRI), i.e. MR thermal imaging and phase contrast MRI to measure the changes of these parameters before and during hypothermia; and then make comparisons with the routine nasopharyngeal and rectal temperature. All these would provide in vivo quantitative data for therapeutic evaluation and promote the optimization.
Detailed description
- Study objects 1.1 Primary object To examine the changes of brain temperature and cerebral blood flow in neonates with HIE before and during (i.e. cooling lasting for 24~36 hr) selective brain cooling. 1.2 Secondary object To compare the differences in temperature between brain (thalamus and HIE lesions) and nasopharynx and rectum of HIE neonates during the cooling.
- Methods Prospective observational study; the MR thermal imaging and phase contrast MRI will be used to estimate brain temperature and cerebral blood flow.
Neonates with HIE who fulfilled the moderate hypothermia criteria will be recruited from the neonatal intensive care units. MR scans will be performed twice after informed parental consent. The first scan will be before the hypothermia and the second scan will be during the hypothermia. The first scan will be performed while the neonate is still in the intensive care unit. At the time of the second MR scan, the neonate is still in the intensive care unit, and the neonate in hypothermia group is receiving the brain selective cooling. Sedation would be used if required in these babies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 6 hours to 4 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates with hypoxic-ischemic encephalopathy who fulfill the moderate hypothermia criteria
Key inclusion criteria (2 listed)
- Neonates in the neonatal intensive care unit who fulfill the hypothermia criteria for treating the hypoxic ischemic encephalopathy and who are scheduled to have an MRI for evaluation of the extent of their injury.
- Parents, clinicians and physician consent to perform evaluation of MRI before and during the hypothermia.
Key exclusion criteria (3 listed)
- Neonates too unstable to have MRI exam, defined by being more than 40% oxygen on the ventilator.
- Hypothermia treatment interruption caused by potential factors.
- Neonates with central nervous system infection,intracranial hemorrhage and brain parenchyma lesions caused by trauma.
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 |
|---|---|---|
| Magnetic resonance imagingMagnetic resonance imaging will be used to estimate brain temperature and cerebral blood flow | Device | – |
Primary outcome
Cooling-induced changes in brain temperature and cerebral blood flow
Time frame: before and during (cooling lasting for 24~36 hr) the hypothermia
Magnetic resonance imaging will be used to measure the changes of brain temperature and cerebral blood flow before and during the brain selective cooling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Hypoxic-Ischemic Encephalopathy
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Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
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Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
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Neuro-MoD: Neuroplasticity With Motor Development
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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.
Chao Jin, Phd contact
Chao Jin, Phd principal investigator
First Affiliated Hospital Xi'an Jiaotong University
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 First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 14 Mar 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chao Jin, Phd (jinny.369@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cooling-induced changes in brain temperature and cerebral blood flow (time frame: before and during (cooling lasting for 24~36 hr) the hypothermia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2017.