Cognitive Development After Pediatric Liver Transplantation

Cognitive Development After Pediatric Live Transplantation Clinical Trial

Official title:

Cognitive Development After Pediatric Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03778983
• Other study ID #: CDPLT
• Status: Completed
• Start date: December 20, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: March 2022
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Development After Pediatric Live Transplantation

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intelligence function evaluated by Wechsler Intelligence Scale IV	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.	at least 1 year after pediatric live transplantation