Pediatric Liver TransplantationrSO2-LDLTNCT04518332
Intraoperative Cerebral and Renal Tissue Oxygen Saturation and Pediatric Living Donor Liver Transplantation Prognosis.
An observational study of Pediatric Liver Transplantation and Developmental Delay, run by RenJi Hospital at 1 site in China.
Trial summary
This rSO2 study is a prospective clinical study. The purpose of the rSO2 study is to investigate whether there is a correlation between the intraoperative cerebral and renal tissue oxygen saturation and the incidence of developmental and socioemotional delay after living donor liver transplantation for children. Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Pediatric Liver Transplantation, Developmental Delay, Postoperative Complications
- How many people
- 123 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 31 Dec 2024
- 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 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Study population: This study will enroll patients aged from 6 to 36 months old who are scheduled for elective standard living-donor liver transplantation and have signed informed consent before the surgery.
Who may be able to join
- Pediatric patients (6 months< the Moon's age <36 months) who will receive standard living-donor liver transplantation (LDLT) in Renji Hospital.
Who cannot join
- Forehead skin infection, A history of liver transplantation, Multivisceral transplantation, Refused to participate the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Pudong, Shanghai Municipality, 200127
Dan Huang, 15921108822, huangdan@renji.com
About this study
Official title: Association of Intraoperative Cerebral and Renal Tissue Oxygen Saturation With Developmental and Socioemotional Delay and Postoperative Complications After Living Donor Liver Transplantation for Children: an Observational Study.
This rSO2 study is a prospective clinical study. The purpose of the rSO2 study is to investigate whether there is a correlation between the intraoperative cerebral and renal tissue oxygen saturation and the incidence of developmental and socioemotional delay after living donor liver transplantation for children. This study will also investigate whether intraoperative cerebral and renal tissue oxygen saturation are related to postoperative complications.
Read the detailed description
There is high incidence of developmental and socioemotional delay and postoperative complications in pediatric living donor liver transplantation patients. In this prospective observational clinical study, the investigators aim to investigate the correlation between the intraoperative cerebral and renal tissue oxygen saturation and the incidence of developmental and socioemotional delay and postoperative complications. This study will enroll patients aged from 6 to 36 months old who are scheduled for elective standard living-donor liver transplantation and have signed informed consent before the surgery.
- Conditions
- Pediatric Liver Transplantation, Developmental Delay, Postoperative Complications, Socioemotional Delay
- Medical subject headings
- Learning Disabilities, Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Developmental delay
Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.
Measured: 10days
Developmental delay
Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.
Measured: 1 month
Developmental delay
Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.
Measured: 3 months
Developmental delay
Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.
Measured: 6 months
Developmental delay
Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.
Measured: 1 year
Developmental delay
Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.
Measured: 2 years
Developmental delay
Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.
Measured: 3 years
Socioemotional Delay
Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.
Measured: 10days
Socioemotional Delay
Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.
Measured: 1 month
Socioemotional Delay
Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.
Measured: 3 months
Socioemotional Delay
Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.
Measured: 6 months
Socioemotional Delay
Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.
Measured: 1 year
Socioemotional Delay
Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.
Measured: 2 years
Socioemotional Delay
Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.
Measured: 3 years
Secondary outcomes (1)
Postoperative complications
Postoperative complications including Cardiovascular system, respiratory system, digestive system, urinary system, blood system will be screened.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Sep 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Liver TransplantationStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weifen Yu, MD,PhD, Study director, Renji Hospital, School of Medicine, Shanghai Jiaotong University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518332
- Sponsor's protocol ID
- 20200808
- Acronym
- rSO2-LDLT
- Status last verified
- Sep 2021
- First submitted
- 16 Aug 2020
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Intraoperative Cerebral and Renal Tissue Oxygen Saturation With Developmental and Socioemotional Delay and Postoperative Complications After Living Donor Liver Transplantation for Children: an Observational Study.
- ClinicalTrials.gov ID
- NCT04518332
- Acronym / sponsor ID
- rSO2-LDLT / 20200808
- Conditions
- Pediatric Liver Transplantation, Developmental Delay, Postoperative Complications, Socioemotional Delay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Aug 2020 (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.
This rSO2 study is a prospective clinical study. The purpose of the rSO2 study is to investigate whether there is a correlation between the intraoperative cerebral and renal tissue oxygen saturation and the incidence of developmental and socioemotional delay after living donor liver transplantation for children. This study will also investigate whether intraoperative cerebral and renal tissue oxygen saturation are related to postoperative complications.
Detailed description
There is high incidence of developmental and socioemotional delay and postoperative complications in pediatric living donor liver transplantation patients. In this prospective observational clinical study, the investigators aim to investigate the correlation between the intraoperative cerebral and renal tissue oxygen saturation and the incidence of developmental and socioemotional delay and postoperative complications. This study will enroll patients aged from 6 to 36 months old who are scheduled for elective standard living-donor liver transplantation and have signed informed consent before the surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will enroll patients aged from 6 to 36 months old who are scheduled for elective standard living-donor liver transplantation and have signed informed consent before the surgery.
Key inclusion criteria (1 listed)
- Pediatric patients (6 months< the Moon's age <36 months) who will receive standard living-donor liver transplantation (LDLT) in Renji Hospital.
Key exclusion criteria (1 listed)
- Forehead skin infection, A history of liver transplantation, Multivisceral transplantation, Refused to participate the study
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
Developmental delay
Time frame: 10days
Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.
Developmental delay
Time frame: 1 month
Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.
Developmental delay
Time frame: 3 months
Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.
Developmental delay
Time frame: 6 months
Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.
Developmental delay
Time frame: 1 year
Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.
Developmental delay
Time frame: 2 years
Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.
Developmental delay
Time frame: 3 years
Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.
Socioemotional Delay
Time frame: 10days
Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.
Socioemotional Delay
Time frame: 1 month
Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.
Socioemotional Delay
Time frame: 3 months
Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.
Socioemotional Delay
Time frame: 6 months
Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.
Socioemotional Delay
Time frame: 1 year
Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.
Socioemotional Delay
Time frame: 2 years
Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.
Socioemotional Delay
Time frame: 3 years
Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.
1 secondary outcome
Postoperative complications
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
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Health Advocate for Children After Liver Transplant
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A Survey on Growth Development in Children After Liver Transplantation
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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.
Weifen Yu, MD,PhD study director
Renji Hospital, School of Medicine, Shanghai Jiaotong University, China
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 Pediatric Liver Transplantation and Developmental Delay, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Huang, M.S. (+86 15921108822, huangdan363@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developmental delay (time frame: 10days). The study lists 14 primary outcomes in all. 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 4 Oct 2021.