Clinical trial NCT06018831: Urine and Ultrasound Screening for Kidney Disease in Children
Official title: Urine and Ultrasound Screening for Kidney Disease in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Diseases
Diagnostic Techniques
Ultrasound
Urinalysis
Child, Only
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Kunshan City Maternal and Child Health Hospital
name: Qidong City Maternal and Child Health Hospital
First posted: 2023-08-31
Enrollment: 13000
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Prevalence, incidence, and incidence of renal disease progression in children with CKD
timeFrame: From baseline to the third or sixth year of the study
Secondary outcomes:
measure: Urine metabolomic and proteomic profiles in KunQi Cohort
timeFrame: From baseline to the third or sixth year of the study
measure: Blood metabolomic and DNA profiles in KunQi Cohort
timeFrame: From baseline to the third or sixth year of the study
measure: Potential risk factors asked within questionnaire for the onset, development and prognosis of CKD in children
timeFrame: From baseline to the third or sixth year of the study
Other outcomes:
Locations:
city: Nantong
country: China
facility: Qidong City Maternal and Child Health Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Kunshan City Maternal and Child Health Hospita
state: Jiangsu
Study officials:
References:
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.
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.
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.