Urine and Ultrasound Screening for Kidney Disease in Children

Not Applicable

Recruiting

• Conditions: Diagnostic Techniques; Ultrasound; Urinalysis; Kidney Diseases; Child, Only
• Interventions: Other: Urine and Ultrasound Screening

• Registration Number: NCT06018831
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study Start: 2022-04-12
• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-08-29
• Study First Posted: 2023-08-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2028-02
• Study Completion: 2028-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 13000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Urine and Ultrasound Screening	Urine and Ultrasound Screening	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)

Primary Outcome Measures

Name	Time	Method
Prevalence, incidence, and incidence of renal disease progression in children with CKD	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.

Secondary Outcome Measures

Name	Time	Method
Urine metabolomic and proteomic profiles in KunQi Cohort	From baseline to the third or sixth year of the study	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.
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	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.
Blood metabolomic and DNA profiles in KunQi Cohort	From baseline to the third or sixth year of the study	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.

Trial Locations

Locations (2)

Qidong City Maternal and Child Health Hospital; 🇨🇳 Nantong, Jiangsu, China

Kunshan City Maternal and Child Health Hospita; 🇨🇳 Suzhou, Jiangsu, China