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Cognitive Development After Pediatric Liver Transplantation

Sponsor
RenJi Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03778983
Collaborator
(none)
130
Enrollment
1
Location
5.3
Actual Duration (Months)
24.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the cognitive performance after pediatric live transplantation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    130 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Cognitive Development After Pediatric Liver Transplantation
    Actual Study Start Date :
    Dec 20, 2018
    Actual Primary Completion Date :
    May 30, 2019
    Actual Study Completion Date :
    May 30, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Pediatric Live Transplantation Group

    Children who underwent pediatric Ltx at RenJi Hospital before 12 month, and now age between 2 and 7 years;

    Outcome Measures

    Primary Outcome Measures

    1. Intelligence function evaluated by Wechsler Intelligence Scale IV [at least 1 year after pediatric live transplantation]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 7 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Pediatric patients accepted Live Transplantation before 12 month, and now age between 2 and 7 years;

    2. residency in China;

    3. sufficient Chinese language skills;

    4. at least 1 year post-Ltx;

    5. no acute diseases;

    6. no mental handicap.

    Exclusion Criteria:

    1. Re-transplantation

    2. Patients with localized or systemic infection

    3. Patients cor-morbid with auto-immune disease

    4. Combined liver and kidney transplantation

    5. Lack of informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Renji Hospital, School of Medicine, Shanghai Jiaotong University Shanghai Shanghai China 200127

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    • Study Chair: Diansan Su, MD, Anesthesiology Department Renji Hospital, Shanghai

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT03778983
    Other Study ID Numbers:
    • CDPLT
    First Posted:
    Dec 19, 2018
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by RenJi Hospital
    Cognitive Development
    Pediatric Live Transplantation

    Study Results

    No Results Posted as of Apr 6, 2022