<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/NCT03778983</url>
  </required_header>
  <id_info>
    <org_study_id>CDPLT</org_study_id>
    <nct_id>NCT03778983</nct_id>
  </id_info>
  <brief_title>Cognitive Development After Pediatric Liver Transplantation</brief_title>
  <official_title>Cognitive Development After Pediatric Liver Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RenJi Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the cognitive performance after pediatric live&#xD;
      transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the last 20 years, survival rates after pediatric liver transplantation (Ltx) have&#xD;
      increased steadily. Today, pediatric Ltx is a well-established treatment for a variety of&#xD;
      liver diseases in their final stage. Even in relative indications (i.e. certain metabolic&#xD;
      diseases), liver transplantation is a promising treatment option that actually is becoming&#xD;
      increasingly important in clinical practice .&#xD;
&#xD;
      Importantly, childhood cognitive ability is highly predictive for educational achievement and&#xD;
      later occupational outcomes as well as health behavior . Current research indicates that&#xD;
      liver transplanted children are at higher risk for developing cognitive deficits compared to&#xD;
      the age-matched normal population .&#xD;
&#xD;
      The aim of present study is to evaluate the cognitive development after pediatric liver&#xD;
      transplantation. The investigators expect to understand of the association between cognitive&#xD;
      deficits and certain disease-related variables, which may be contribute to optimizing&#xD;
      clinical care of these patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">May 30, 2019</completion_date>
  <primary_completion_date type="Actual">May 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Intelligence function evaluated by Wechsler Intelligence Scale IV</measure>
    <time_frame>at least 1 year after pediatric live transplantation</time_frame>
    <description>Wechsler Intelligence Scale IV (WISC-IV) is the newly released and completely revised Chineseversion of the Wechsler Intelligence Scale for Children-fourth edition(WISC-IV) . A global intelligence score, the Total IQ, is comprised of four index scores: (i) Verbal Comprehension Index, which includes the subtests Similarities, Vocabulary and Comprehension; (ii) Perceptual Reasoning Index, which consists of Block Design, Picture Concepts and Matrix Reasoning; (iii) Working Memory Index, which encompasses the subtests Digit Span and Letter Number Sequencing; (iv) Processing Speed Index, which is composed of the subtests Coding and Symbol Search. The normative populations mean (M) is 100, and the standard deviation (SD) is 15 for all indices.The lower the intelligence score, the worse outcome.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">130</enrollment>
  <condition>Cognitive Development After Pediatric Live Transplantation</condition>
  <arm_group>
    <arm_group_label>Pediatric Live Transplantation Group</arm_group_label>
    <description>Children who underwent pediatric Ltx at RenJi Hospital before 12 month, and now age between 2 and 7 years;</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study chooses children who underwent pediatric Ltx before 12 month at RenJi Hospital ,&#xD;
        Chinese, now age before 2 and 7 years . Inclusion criteria were as follows: (1) age&#xD;
        between2 and7 years, (2) residency in China, (3) sufficient Chinese language skills, (4) at&#xD;
        least 1 year post-Ltx, (5) no acute diseases and (6) no mental handicap.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pediatric patients accepted Live Transplantation before 12 month, and now age between&#xD;
             2 and 7 years;&#xD;
&#xD;
          2. residency in China;&#xD;
&#xD;
          3. sufficient Chinese language skills;&#xD;
&#xD;
          4. at least 1 year post-Ltx;&#xD;
&#xD;
          5. no acute diseases;&#xD;
&#xD;
          6. no mental handicap.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Re-transplantation&#xD;
&#xD;
          2. Patients with localized or systemic infection&#xD;
&#xD;
          3. Patients cor-morbid with auto-immune disease&#xD;
&#xD;
          4. Combined liver and kidney transplantation&#xD;
&#xD;
          5. Lack of informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Chinese</gender_description>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Diansan Su, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Anesthesiology Department Renji Hospital, Shanghai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Renji Hospital, School of Medicine, Shanghai Jiaotong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>March 25, 2022</last_update_submitted>
  <last_update_submitted_qc>March 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cognitive Development</keyword>
  <keyword>Pediatric Live Transplantation</keyword>
  <!-- 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/NCT03778983
org study id: CDPLT
nct id: NCT03778983
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the cognitive performance after pediatric live
      transplantation.
During the last 20 years, survival rates after pediatric liver transplantation (Ltx) have
      increased steadily. Today, pediatric Ltx is a well-established treatment for a variety of
      liver diseases in their final stage. Even in relative indications (i.e. certain metabolic
      diseases), liver transplantation is a promising treatment option that actually is becoming
      increasingly important in clinical practice .

      Importantly, childhood cognitive ability is highly predictive for educational achievement and
      later occupational outcomes as well as health behavior . Current research indicates that
      liver transplanted children are at higher risk for developing cognitive deficits compared to
      the age-matched normal population .

      The aim of present study is to evaluate the cognitive development after pediatric liver
      transplantation. The investigators expect to understand of the association between cognitive
      deficits and certain disease-related variables, which may be contribute to optimizing
      clinical care of these patients.
observational model: Cohort
time perspective: Retrospective
measure: Intelligence function evaluated by Wechsler Intelligence Scale IV
time frame: at least 1 year after pediatric live transplantation
description: Wechsler Intelligence Scale IV (WISC-IV) is the newly released and completely revised Chineseversion of the Wechsler Intelligence Scale for Children-fourth edition(WISC-IV) . A global intelligence score, the Total IQ, is comprised of four index scores: (i) Verbal Comprehension Index, which includes the subtests Similarities, Vocabulary and Comprehension; (ii) Perceptual Reasoning Index, which consists of Block Design, Picture Concepts and Matrix Reasoning; (iii) Working Memory Index, which encompasses the subtests Digit Span and Letter Number Sequencing; (iv) Processing Speed Index, which is composed of the subtests Coding and Symbol Search. The normative populations mean (M) is 100, and the standard deviation (SD) is 15 for all indices.The lower the intelligence score, the worse outcome.
arm group label: Pediatric Live Transplantation Group
description: Children who underwent pediatric Ltx at RenJi Hospital before 12 month, and now age between 2 and 7 years;
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: Chinese
minimum age: 2 Years
maximum age: 7 Years
last name: Diansan Su, MD
role: Study Chair
affiliation: Anesthesiology Department Renji Hospital, Shanghai
facility: 
country: China
responsible party type: Sponsor