MRI of Neonate With HIE Before and During the Moderate Hypothermia

NCT03079492 | Unknown

• 1 other identifier: 2016YFC0100300HIE01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypoxic-Ischemic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• 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

  before and during (cooling lasting for 24~36 hr) the hypothermia

Interventions

Magnetic resonance imaging DEVICE

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

Eligibility Criteria

• Age: 6 Hours - 4 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates with hypoxic-ischemic encephalopathy who fulfill the moderate hypothermia criteria

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

the First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Chao Jin, Phd

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Jin, Phd

CONTACT

jinny.369@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 14, 2017
• Study Start: June 1, 2017
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2020
• Last Updated: March 14, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)