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NCT02224586 Clinical Trial

Resting State Functional Magnetic Resonance Imaging Study of Jaundice Infants Before and After Light Treatment.

Jaundice Clinical Trial

Official title:
Resting State Functional Magnetic Resonance Imaging Study of Jaundice Infants Before and After Light Treatment.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02224586
Other study ID # HNU_AH_jaundice fMRI
Secondary ID
Status Recruiting
Phase N/A
First received August 20, 2014
Last updated August 21, 2014
Start date August 2014
Est. completion date July 2015

Study information
Verified date August 2014
Source Hangzhou Normal University
Contact Xiao-Bao Xue
Email baobao871015@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

It is just an observation study. The investigates want to explore the signal changes of resting state functional Magnetic resonance Imaging (fMRI) after light treatment in jaundice infants. Signal changes contain blood oxygenation level dependent (BOLD) and arterial spin labeling (ASL).Indicator of BOLD is amplitude of low-frequency fluctuation（ALFF).Indicator of ASL is cerebral blood flow (CBF).

The investigates assume that the children with jaundice after light therapy, ALFF and CBF will change. Focus on the globus pallidus and subthalamic nuclei. The two brain regions were proved to be abnormal in MRI T1, T2 structure signal in kernicterus.

Doctors observe the status of infants aside.Using monitoring probe can see clearly.

Description:

resting state fMRI scan light therapy the second time resting state fMRI scan

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date July 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group N/A to 28 Days
Eligibility Inclusion Criteria:

- hyperbilirubinemia

Exclusion Criteria:

- asphyxia

- cerebral dysgenesis

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• light treatment
clinical routine treatment according to the doctor's advice

Locations
Country Name City State
China Center for Cognition and Brain Disorders Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Hangzhou Normal University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary amplitude of low-frequency fluctuation change before and after light treatment It is indicator of blood oxygenation level dependent. before and after light treatment Yes
Secondary cerebral blood flow change before after light treatment It is indicator of arterial spin labeling. before and after light treatment Yes
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