NCT04518332

Brief 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. This study will also investigate whether intraoperative cerebral and renal tissue oxygen saturation are related to postoperative complications.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

4.3 years

First QC Date

August 16, 2020

Last Update Submit

September 26, 2021

Conditions

Pediatric Liver TransplantationDevelopmental DelayPostoperative ComplicationsSocioemotional Delay

Outcome Measures

Primary Outcomes (14)

  • Developmental delay

    Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.

    10days

  • Developmental delay

    Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.

    1 month

  • Developmental delay

    Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.

    3 months

  • Developmental delay

    Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.

    6 months

  • Developmental delay

    Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.

    1 year

  • Developmental delay

    Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.

    2 years

  • Developmental delay

    Developmental delay will be measured using Age and Stage Questionnaire(ASQ) after surgery.

    3 years

  • Socioemotional Delay

    Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.

    10days

  • Socioemotional Delay

    Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.

    1 month

  • Socioemotional Delay

    Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.

    3 months

  • Socioemotional Delay

    Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.

    6 months

  • Socioemotional Delay

    Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.

    1 year

  • Socioemotional Delay

    Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.

    2 years

  • Socioemotional Delay

    Socioemotional Delay will be measured using Age and Stage Questionnaire: Social Emotional(ASQ-SE) after surgery.

    3 years

Secondary Outcomes (1)

  • Postoperative complications

    30 days

Eligibility Criteria

Age6 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Pediatric patients (6 months\< the Moon's age \<36 months) who will receive standard living-donor liver transplantation (LDLT) in Renji Hospital.

You may not qualify if:

  • Forehead skin infection, A history of liver transplantation, Multivisceral transplantation, Refused to participate the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Pudong, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Learning DisabilitiesPostoperative Complications

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersPathologic Processes

Study Officials

  • Weifen Yu, MD,PhD

    Renji Hospital, School of Medicine, Shanghai Jiaotong University, China

    STUDY DIRECTOR

Central Study Contacts

Dan Huang, M.S.

CONTACT

+86 15921108822huangdan363@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2020

First Posted

August 19, 2020

Study Start

September 1, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 4, 2021

Record last verified: 2021-09

Locations

CN(1)