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临床试验/NCT06018831
NCT06018831招募中不适用

Urine and Ultrasound Screening for Kidney Disease in Children

Children's Hospital of Fudan University2 个研究点 分布在 1 个国家目标入组 13,000 人开始时间: 2022年4月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
13,000
试验地点
2
主要终点
Prevalence, incidence, and incidence of renal disease progression in children with CKD

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
— 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All consecutive live newborn infants(regardless of physical condition)
  • Complete at least 3 years of follow-up

排除标准

  • Declining the screening

结局指标

主要结局

Prevalence, incidence, and incidence of renal disease progression in children with CKD

时间窗: From baseline to the third or sixth year of the study

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.

次要结局

  • Urine metabolomic and proteomic profiles in KunQi Cohort(From baseline to the third or sixth year of the study)
  • Potential risk factors asked within questionnaire for the onset, development and prognosis of CKD in children(From baseline to the third or sixth year of the study)
  • Blood metabolomic and DNA profiles in KunQi Cohort(From baseline to the third or sixth year of the study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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