Urine and Ultrasound Screening for Kidney Disease in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Urine and Ultrasound Screening.
- Who it may be relevant to
- Registry conditions: Kidney Diseases, Diagnostic Techniques, Ultrasound, Urinalysis. Basic parameters: up to 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Urine and Ultrasound Screening
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 fo
Primary outcome measures
- Prevalence, incidence, and incidence of renal disease progression in children with CKD [Time frame: From baseline to the third or sixth year of the study]
Secondary outcome measures (3)
- Urine metabolomic and proteomic profiles in KunQi Cohort [Time frame: From baseline to the third or sixth year of the study]
- Blood metabolomic and DNA profiles in KunQi Cohort [Time frame: 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 [Time frame: From baseline to the third or sixth year of the study]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
China · 2 centers
- Qidong City Maternal and Child Health Hospital — Nantong
- Kunshan City Maternal and Child Health Hospita — Suzhou
Publications
- 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. PMID 29848771
- 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. PMID 30983458
- 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. PMID 17943322
- Shen Y, Liu T, Liu J, Han X, Wu J, Xie L, Chen X, Xu B, Sun Y, Xu S, Zhang Q, Xie N, Zhang L, Ji J, Mo W, Liu Y, Shi X, Shen J, Qiu W, Huang J, Shen Q, Zhai Y, Xu H; KQBC group. Kun-Qi birth cohort (KQBC) study for the incidence, aetiology and risk factors of chronic kidney disease in Chinese children: a cohort profile. BMJ Open. 2025 Aug 16;15(8):e102702. doi: 10.1136/bmjopen-2025-102702. PMID 40819875
Identifiers
NCT: NCT06018831 · 2021YFC2500202