Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200127, China
Completed
NCT Number: NCT03778983
Cognitive Development After Pediatric Liver Transplantation
The purpose of this study is to investigate the cognitive performance after pediatric live transplantation.
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Notify MeKey information
Age range
2 year–7 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Intelligence function evaluated by Wechsler Intelligence Scale IV
Time frame: 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.
Sponsors and collaborators
Lead sponsor
RenJi Hospital
Other
Registry information
Important dates
- Study start
- 2018
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Dec 19, 2018
- Registry last updated
- Apr 6, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.