Cognitive Development After Pediatric Liver Transplantation
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200127
- Renji Hospital, School of Medicine, Shanghai Jiaotong University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pediatric patients accepted Live Transplantation before 12 month, and now age between 2 and 7 years;
- residency in China;
- sufficient Chinese language skills;
- at least 1 year post-Ltx;
- no acute diseases;
- no mental handicap.
Exclusion Criteria:
- Re-transplantation
- Patients with localized or systemic infection
- Patients cor-morbid with auto-immune disease
- Combined liver and kidney transplantation
- Lack of informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Pediatric Live Transplantation Group
Children who underwent pediatric Ltx at RenJi Hospital before 12 month, and now age between 2 and 7 years;
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Intelligence function evaluated by Wechsler Intelligence Scale IV
Time Frame: at least 1 year after pediatric live transplantation
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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.
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at least 1 year after pediatric live transplantation
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Diansan Su, MD, Anesthesiology Department Renji Hospital, Shanghai
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CDPLT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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