Cognitive Development After Pediatric Liver Transplantation

NCT ID: NCT03778983

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-20
• Study Completion Date: 2019-05-30

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.

Conditions

Cognitive Development After Pediatric Live Transplantation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Pediatric Live Transplantation Group

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diansan Su, MD

Role: STUDY_CHAIR

Anesthesiology Department Renji Hospital, Shanghai

Locations

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CDPLT

Identifier Type: -

Identifier Source: org_study_id