Urine and Ultrasound Screening for Kidney Disease in Children
Primary Purpose
Kidney Diseases, Diagnostic Techniques, Ultrasound
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Urine and Ultrasound Screening
Sponsored by
About this trial
This is an interventional screening trial for Kidney Diseases
Eligibility Criteria
Inclusion Criteria: All consecutive live newborn infants(regardless of physical condition) Complete at least 3 years of follow-up Exclusion Criteria: Declining the screening Missing
Sites / Locations
- Qidong City Maternal and Child Health HospitalRecruiting
- Kunshan City Maternal and Child Health HospitaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Urine and Ultrasound Screening
Arm Description
About 10,000 children called KunQi Cohort are born in Jiangsu Province(8,000 in Kunshan and 2,000 in Qidong) and about 3,000 born in Shanghai. Children will receive urine and ultrasound screening in 0-3 months ,and complete 3 to 6 years of follow-up( at least one type screening every year)
Outcomes
Primary Outcome Measures
Prevalence, incidence, and incidence of renal disease progression in children with CKD
The number of CKD patients diagnosed according to the routine diagnosis and treatment of the department of nephrology in Children's Hospital of Fudan University in the 3-6 year observation period accounted for the percentage of the total cases studied.
Secondary Outcome Measures
Urine metabolomic and proteomic profiles in KunQi Cohort
9,000 children's urine samples (50ml) will be stored as biospecimen retention at -80°C only once within one year, another 1,000 children's urine samples (50ml) will be stored also as biospecimen retention at -80°C once a year.
Biospecimen retention will be used to characterize the urinary and metabolome and proteome in children also expect to identify urine biomarkers for the early diagnosis of CKD.
Blood metabolomic and DNA profiles in KunQi Cohort
Dry blood filter paper(120ul) will be stored once a year when he or she has a blood routine for metabolomic study and DNA extraction, aiming to identify blood metabolomic biomarkers and DNA mutations for the early diagnosis of CKD.
Potential risk factors asked within questionnaire for the onset, development and prognosis of CKD in children
Every child's patient will be asked to complete 3-6 year follow-up questionnaire once a year(include Children Kidney Health Survey for first-year baseline questionnaire and Chilren Kidney Health Survey as every year's follow-up questionnaire) when undergoing routine child health checkups, which includes health conditions and kidney disease related events including family history, mother's height and weight before and after pregnancy (used to calculate BMI), parents' smoking and drinking history, whether the mother takes antihypertensive drugs and the type, parents' occupational exposure history, drinking water quality, take-out frequency, mother's first child bearing age and the age of this child bearing, newborn hospitalization history. These potential risk factors analyzed by statistical methods are aimed to predict the onset, development and prognosis of CKD in children.
Full Information
NCT ID
NCT06018831
First Posted
February 3, 2023
Last Updated
October 18, 2023
Sponsor
Children's Hospital of Fudan University
Collaborators
Kunshan City Maternal and Child Health Hospital, Qidong City Maternal and Child Health Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06018831
Brief Title
Urine and Ultrasound Screening for Kidney Disease in Children
Official Title
Urine and Ultrasound Screening for Kidney Disease in Children
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2022 (Actual)
Primary Completion Date
February 2028 (Anticipated)
Study Completion Date
February 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University
Collaborators
Kunshan City Maternal and Child Health Hospital, Qidong City Maternal and Child Health Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to early detect kidney disease in the natural population cohort of children by urine and ultrasound screening, to assist in the precise prevention and treatment of children's kidney disease, and to establish a risk prediction system for children's kidney disease. About 10,000 children called KunQi Cohort are born in Jiangsu Province(8,000 in Kunshan and 2,000 in Qidong) and about 3,000 born in Shanghai. Through the project, child who is found with abnormal urine or ultrasound result will be referred to Children's Hospital of Fudan University to get further examination and treatment.
Detailed Description
Chronic kidney disease (CKD) often has an insidious onset. Early detection of CKD and more aggressive treatment and monitoring of high-risk CKD patients at risk of progression are the consensus of current medical practice. However, there is currently no CKD risk prediction system for the Chinese population, especially children. The main goal of this project is to establish a risk prediction system for children's kidney disease, and to assist in the precise prevention and treatment of children's kidney disease. The project is based on the "urine and ultrasound screening" strategy that has been carried out for more than ten years in Shanghai, using a non-invasive and effective screening method in the natural population cohort of children, in order to detect kidney disease in the early stage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Diagnostic Techniques, Ultrasound, Urinalysis, Child, Only
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Urine and Ultrasound Screening
Arm Type
Experimental
Arm Description
About 10,000 children called KunQi Cohort are born in Jiangsu Province(8,000 in Kunshan and 2,000 in Qidong) and about 3,000 born in Shanghai. Children will receive urine and ultrasound screening in 0-3 months ,and complete 3 to 6 years of follow-up( at least one type screening every year)
Intervention Type
Other
Intervention Name(s)
Urine and Ultrasound Screening
Intervention Description
When an infant was born, he/she will receive the first urine and ultrasound screening in 3 months in Kunshan/Qidong City Maternal and Child Health Hospital.In Kunqi Cohort, 9,000 will complete 3 years follow-up(urine screening once every year, another ultrasound screening in 24-30 months). Urine sample (50ml) will be stored only once within one year. Dry blood filter paper(120ul) will be stored once a year when he or she has a blood routine for future study.1,000 children will complete 6 year follow-up(receive urine and ultrasound screening once every year). Urine sample (50ml) will be stored once a year. Dry blood filter paper(120ul) will be stored once a year when he or she has a blood routine for future study. The 14 urine test items include: leukocytes, urobilinogen, microalbumin, protein, bilirubin, glucose, ascorbic acid, specific gravity, ketone bodies, nitrite, creatinine, pH, occult blood, and urinary calcium. Ultrasound test will screen for kidneys, ureters and the bladder.
Primary Outcome Measure Information:
Title
Prevalence, incidence, and incidence of renal disease progression in children with CKD
Description
The number of CKD patients diagnosed according to the routine diagnosis and treatment of the department of nephrology in Children's Hospital of Fudan University in the 3-6 year observation period accounted for the percentage of the total cases studied.
Time Frame
From baseline to the third or sixth year of the study
Secondary Outcome Measure Information:
Title
Urine metabolomic and proteomic profiles in KunQi Cohort
Description
9,000 children's urine samples (50ml) will be stored as biospecimen retention at -80°C only once within one year, another 1,000 children's urine samples (50ml) will be stored also as biospecimen retention at -80°C once a year.
Biospecimen retention will be used to characterize the urinary and metabolome and proteome in children also expect to identify urine biomarkers for the early diagnosis of CKD.
Time Frame
From baseline to the third or sixth year of the study
Title
Blood metabolomic and DNA profiles in KunQi Cohort
Description
Dry blood filter paper(120ul) will be stored once a year when he or she has a blood routine for metabolomic study and DNA extraction, aiming to identify blood metabolomic biomarkers and DNA mutations for the early diagnosis of CKD.
Time Frame
From baseline to the third or sixth year of the study
Title
Potential risk factors asked within questionnaire for the onset, development and prognosis of CKD in children
Description
Every child's patient will be asked to complete 3-6 year follow-up questionnaire once a year(include Children Kidney Health Survey for first-year baseline questionnaire and Chilren Kidney Health Survey as every year's follow-up questionnaire) when undergoing routine child health checkups, which includes health conditions and kidney disease related events including family history, mother's height and weight before and after pregnancy (used to calculate BMI), parents' smoking and drinking history, whether the mother takes antihypertensive drugs and the type, parents' occupational exposure history, drinking water quality, take-out frequency, mother's first child bearing age and the age of this child bearing, newborn hospitalization history. These potential risk factors analyzed by statistical methods are aimed to predict the onset, development and prognosis of CKD in children.
Time Frame
From baseline to the third or sixth year of the study
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All consecutive live newborn infants(regardless of physical condition)
Complete at least 3 years of follow-up
Exclusion Criteria:
Declining the screening
Missing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yihui Zhai
Phone
+8613916488230
Email
marinezyh@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Xu, PhD.MD.
Phone
+8602164932829
Email
hxu@shmu.edu.cn
Facility Information:
Facility Name
Qidong City Maternal and Child Health Hospital
City
Nantong
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JuanJuan Wu
Phone
+8613862875600
Facility Name
Kunshan City Maternal and Child Health Hospita
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SuXiang Xu
Phone
+8613912668435
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29848771
Citation
Gong Y, Zhang Y, Shen Q, Xiao L, Zhai Y, Bi Y, Shen J, Chen H, Li Y, Xu H. Early detection of congenital anomalies of the kidney and urinary tract: cross-sectional results of a community-based screening and referral study in China. BMJ Open. 2018 May 30;8(5):e020634. doi: 10.1136/bmjopen-2017-020634.
Results Reference
background
PubMed Identifier
30983458
Citation
Gong Y, Xu H, Li Y, Zhou Y, Zhang M, Shen Q, Huang J, Xu H, Bi Y, Chen H, Zhang Y, Wang J. Exploration of postnatal integrated management for prenatal renal and urinary tract anomalies in China. J Matern Fetal Neonatal Med. 2021 Feb;34(3):360-365. doi: 10.1080/14767058.2019.1608176. Epub 2019 Apr 29.
Results Reference
background
PubMed Identifier
17943322
Citation
Zhai YH, Xu H, Zhu GH, Wei MJ, Hua BC, Shen Q, Rao J, Ge J. Efficacy of urine screening at school: experience in Shanghai, China. Pediatr Nephrol. 2007 Dec;22(12):2073-9. doi: 10.1007/s00467-007-0629-5. Epub 2007 Oct 18.
Results Reference
background
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Urine and Ultrasound Screening for Kidney Disease in Children
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