MRI of Neonate With HIE Before & During the Moderate Hypothermia

Status Not yet recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03079492
Study type	Observational [Patient Registry]
Source	First Affiliated Hospital Xi'an Jiaotong University
Contact	Chao Jin, Phd
Email	jinny.369@163.com
Status	Not yet recruiting
Phase	N/A
Start date	June 1, 2017
Completion date	May 31, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

MRI of Neonate With HIE Before and During the Moderate Hypothermia

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms