MRI of Neonate With HIE Before and During the Moderate Hypothermia

Hypoxic-Ischemic Encephalopathy Clinical Trial

Official title:

Magnetic Resonance Imaging of Neonates With Hypoxic Ischemic Encephalopathy Before and During Moderate Hypothermia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03079492
• Other study ID #: 2016YFC0100300HIE01
• Status: Not yet recruiting
• Phase: N/A
• First received: March 8, 2017
• Last updated: March 8, 2017
• Start date: June 1, 2017
• Est. completion date: May 31, 2020

Study information

• Verified date: February 2017
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Chao Jin, Phd
• Email: jinny.369[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Days

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypothermia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Ischemia

Intervention

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

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Xi'an Jiaotong University	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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