Urine and Ultrasound Screening for Kidney Disease in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Urine and Ultrasound Screening for Kidney Disease in Children

Conditions
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Ultrasound, Kidney Diseases, Diagnostic Techniques, Urinalysis, Child, Only

Intervention / Treatment
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* Other: Urine and Ultrasound Screening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urine and Ultrasound Screening<br>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) | Other: Urine and Ultrasound Screening<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From baseline to the third or sixth year of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From baseline to the third or sixth year of the study | 
| 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. | 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 | 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. | From baseline to the third or sixth year of the study |