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

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ClinicalTrials.gov Identifier: NCT02224586
Recruitment Status : Unknown
Verified August 2014 by Ya-Fei Zhu, Hangzhou Normal University.
Recruitment status was:  Recruiting
First Posted : August 25, 2014
Last Update Posted : August 25, 2014
Sponsor:
Information provided by (Responsible Party):
Ya-Fei Zhu, Hangzhou Normal University

Brief 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.


Condition or disease Intervention/treatment
Jaundice Device: light treatment

Detailed Description:
resting state fMRI scan light therapy the second time resting state fMRI scan

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Resting State Functional Magnetic Resonance Imaging Study of Jaundice Infants Before and After Light Treatment.
Study Start Date : August 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Group/Cohort Intervention/treatment
light treatment
clinical routine treatment according to the doctor's advice
Device: light treatment
clinical routine treatment according to the doctor's advice




Primary Outcome Measures :
  1. amplitude of low-frequency fluctuation change before and after light treatment [ Time Frame: before and after light treatment ]
    It is indicator of blood oxygenation level dependent.


Secondary Outcome Measures :
  1. cerebral blood flow change before after light treatment [ Time Frame: before and after light treatment ]
    It is indicator of arterial spin labeling.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
municipal hospitals
Criteria

Inclusion Criteria:

  • hyperbilirubinemia

Exclusion Criteria:

  • asphyxia
  • cerebral dysgenesis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224586


Contacts
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Contact: Xiao-Bao Xue baobao871015@163.com

Locations
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China, Zhejiang
Center for Cognition and Brain Disorders Recruiting
Hangzhou, Zhejiang, China, 311121
Contact: Xiao-Bao Xue       baobao871015@163.com   
Principal Investigator: Ya-Fei Zhu         
Sponsors and Collaborators
Hangzhou Normal University
Investigators
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Principal Investigator: Ya-Fei Zhu Center for Cognition and Brain Disorders,Hangzhou Normal University

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Responsible Party: Ya-Fei Zhu, chief physician, Hangzhou Normal University
ClinicalTrials.gov Identifier: NCT02224586     History of Changes
Other Study ID Numbers: HNU_AH_jaundice fMRI
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: August 25, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms