Cognitive Development After Pediatric Live TransplantationNCT03778983
Cognitive Development After Pediatric Liver Transplantation
An observational study of Cognitive Development After Pediatric Live Transplantation, run by RenJi Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate the cognitive performance after pediatric live transplantation. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Cognitive Development After Pediatric Live Transplantation
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2018to 30 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- Child
Study population: The study chooses children who underwent pediatric Ltx before 12 month at RenJi Hospital , Chinese, now age before 2 and 7 years . Inclusion criteria were as follows: (1) age between2 and7 years, (2) residency in China, (3) sufficient Chinese language skills, (4) at least 1 year post-Ltx, (5) no acute diseases and (6) no mental handicap.
Who may be able to join
- 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.
Who cannot join
- Re-transplantation
- Patients with localized or systemic infection
- Patients cor-morbid with auto-immune disease
- Combined liver and kidney transplantation
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200127
About this study
The purpose of this study is to investigate the cognitive performance after pediatric live transplantation.
Read the 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.
- Keywords
- Cognitive Development, Pediatric Live Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Live Transplantation Group | Children who underwent pediatric Ltx at RenJi Hospital before 12 month, and now age between 2 and 7 years; |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at least 1 year after pediatric live transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start20 Dec 2018
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Development After Pediatric Live TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diansan Su, MD, Study chair, Anesthesiology Department Renji Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778983
- Sponsor's protocol ID
- CDPLT
- Status last verified
- Mar 2022
- First submitted
- 13 Nov 2018
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Development After Pediatric Liver Transplantation
- ClinicalTrials.gov ID
- NCT03778983
- Acronym / sponsor ID
- CDPLT
- Keywords
- Cognitive Development, Pediatric Live Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Live Transplantation Group | – | –Children who underwent pediatric Ltx at RenJi Hospital before 12 month, and now age between 2 and 7 years; |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Age groups
- Child
- Study population
- The study chooses children who underwent pediatric Ltx before 12 month at RenJi Hospital , Chinese, now age before 2 and 7 years . Inclusion criteria were as follows: (1) age between2 and7 years, (2) residency in China, (3) sufficient Chinese language skills, (4) at least 1 year post-Ltx, (5) no acute diseases and (6) no mental handicap.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- Re-transplantation
- Patients with localized or systemic infection
- Patients cor-morbid with auto-immune disease
- Combined liver and kidney transplantation
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diansan Su, MD study chair
Anesthesiology Department Renji Hospital, Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Development After Pediatric Live Transplantation, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intelligence function evaluated by Wechsler Intelligence Scale IV (time frame: at least 1 year after pediatric live transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.