Cognitive Development After Pediatric Liver Transplantation

Completed

• Conditions: Cognitive Development After Pediatric Live Transplantation

• Registration Number: NCT03778983
• Lead Sponsor: RenJi Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-12-14
• Study First Posted: 2018-12-19
• Study Start: 2018-12-20
• Primary Completion: 2019-05-30
• Study Completion: 2019-05-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-25
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China