MRI of Neonate With HIE Before and During the Moderate Hypothermia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2020-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01128673

Hypoxic Ischemic Encephalopathy

WITHDRAWN

Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy(HIE)

NCT05581927

Hypoxic- Ischemic Encephalopathy Whole-Body Hypothermia Brain Injury

WITHDRAWN NA

Magnetic Resonance Imaging and Spectroscopy Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy

NCT01481207

Hypoxic Ischemic Encephalopathy

COMPLETED

Systemic Hypothermia Improves Outcome of Hypoxic-Ischemic Encephalopathy

NCT00817401

Hypoxic-Ischemic Encephalopathy

COMPLETED PHASE1/PHASE2

The Ability of NIRS to Predict Brain Injury in Hypoxic Ischemic Encephalopathy

NCT03835039

HIE - Perinatal Hypoxic - Ischemic Encephalopathy

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

1. 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.
2. 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

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoxic-Ischemic Encephalopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Magnetic resonance imaging

Magnetic resonance imaging will be used to estimate brain temperature and cerebral blood flow

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

6 Hours

Maximum Eligible Age

4 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No