Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-02-09 @ 8:26 PM
Study NCT ID:
NCT03079492
Status:
UNKNOWN
Last Update Posted:
2017-03-14
First Post:
2017-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI of Neonate With HIE Before and During the Moderate Hypothermia
Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Organization:
Study Overview
Official Title:
Magnetic Resonance Imaging of Neonates With Hypoxic Ischemic Encephalopathy Before and During Moderate Hypothermia
Status:
UNKNOWN
Status Verified Date:
2017-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: