Urine and Ultrasound Screening for Kidney Disease in Children

NCT ID: NCT06018831

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 13000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-12
• Study Completion Date: 2028-02-29

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Urine and Ultrasound Screening

Intervention Type: OTHER

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.

Interventions

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 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.

Intervention Type: OTHER

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

• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kunshan City Maternal and Child Health Hospital

UNKNOWN

Sponsor Role: collaborator

Qidong City Maternal and Child Health Hospital

UNKNOWN

Sponsor Role: collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Qidong City Maternal and Child Health Hospital

Nantong, Jiangsu, China

Site Status: RECRUITING

Kunshan City Maternal and Child Health Hospita

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yihui Zhai

Role: CONTACT

marinezyh@163.com

+8613916488230

Hong Xu, PhD.MD.

Role: CONTACT

hxu@shmu.edu.cn

+8602164932829

Facility Contacts

JuanJuan Wu

Role: primary

+8613862875600

SuXiang Xu

Role: primary

+8613912668435

References

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.

Reference Type: BACKGROUND

PMID: 29848771 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30983458 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17943322 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40819875 (View on PubMed)

Other Identifiers

2021YFC2500202

Identifier Type: -

Identifier Source: org_study_id