<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02224586</url>
  </required_header>
  <id_info>
    <org_study_id>HNU_AH_jaundice fMRI</org_study_id>
    <nct_id>NCT02224586</nct_id>
  </id_info>
  <brief_title>Resting State Functional Magnetic Resonance Imaging Study of Jaundice Infants Before and After Light Treatment.</brief_title>
  <official_title>Resting State Functional Magnetic Resonance Imaging Study of Jaundice Infants Before and After Light Treatment.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hangzhou Normal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hangzhou Normal University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is just an observation study. The investigates want to explore the signal changes of&#xD;
      resting state functional Magnetic resonance Imaging (fMRI) after light treatment in jaundice&#xD;
      infants. Signal changes contain blood oxygenation level dependent (BOLD) and arterial spin&#xD;
      labeling (ASL).Indicator of BOLD is amplitude of low-frequency fluctuation（ALFF).Indicator of&#xD;
      ASL is cerebral blood flow (CBF).&#xD;
&#xD;
      The investigates assume that the children with jaundice after light therapy, ALFF and CBF&#xD;
      will change. Focus on the globus pallidus and subthalamic nuclei. The two brain regions were&#xD;
      proved to be abnormal in MRI T1, T2 structure signal in kernicterus.&#xD;
&#xD;
      Doctors observe the status of infants aside.Using monitoring probe can see clearly.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      resting state fMRI scan light therapy the second time resting state fMRI scan&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">March 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>amplitude of low-frequency fluctuation change before and after light treatment</measure>
    <time_frame>before and after light treatment</time_frame>
    <description>It is indicator of blood oxygenation level dependent.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cerebral blood flow change before after light treatment</measure>
    <time_frame>before and after light treatment</time_frame>
    <description>It is indicator of arterial spin labeling.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Jaundice</condition>
  <arm_group>
    <arm_group_label>light treatment</arm_group_label>
    <description>clinical routine treatment according to the doctor's advice</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>light treatment</intervention_name>
    <description>clinical routine treatment according to the doctor's advice</description>
    <arm_group_label>light treatment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        municipal hospitals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hyperbilirubinemia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  asphyxia&#xD;
&#xD;
          -  cerebral dysgenesis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ya-Fei Zhu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Cognition and Brain Disorders,Hangzhou Normal University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiao-Bao Xue</last_name>
    <email>baobao871015@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Center for Cognition and Brain Disorders</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>311121</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiao-Bao Xue</last_name>
      <email>baobao871015@163.com</email>
    </contact>
    <investigator>
      <last_name>Ya-Fei Zhu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hangzhou Normal University</investigator_affiliation>
    <investigator_full_name>Ya-Fei Zhu</investigator_full_name>
    <investigator_title>chief physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Jaundice</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02224586
org study id: HNU_AH_jaundice fMRI
nct id: NCT02224586
lead sponsor: 
has dmc: Yes
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.
resting state fMRI scan light therapy the second time resting state fMRI scan
observational model: Case-Crossover
time perspective: Prospective
measure: amplitude of low-frequency fluctuation change before and after light treatment
time frame: before and after light treatment
description: It is indicator of blood oxygenation level dependent.
measure: cerebral blood flow change before after light treatment
time frame: before and after light treatment
description: It is indicator of arterial spin labeling.
arm group label: light treatment
description: clinical routine treatment according to the doctor's advice
intervention type: Device
intervention name: light treatment
description: clinical routine treatment according to the doctor's advice
arm group label: light treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 28 Days
healthy volunteers: No
last name: Ya-Fei Zhu
role: Principal Investigator
affiliation: Center for Cognition and Brain Disorders,Hangzhou Normal University
last name: Xiao-Bao Xue
email: baobao871015@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Hangzhou Normal University
investigator full name: Ya-Fei Zhu
investigator title: chief physician
mesh term: Jaundice