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NCT Number: NCT06018831

Urine and Ultrasound Screening for Kidney Disease in Children

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.

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Key information

Conditions

Kidney Diseases Child, Only Diagnostic Techniques Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Ultrasound Urinalysis Urogenital Diseases Urologic Diseases

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qidong City Maternal and Child Health Hospital, Nantong, Jiangsu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urine and Ultrasound Screening

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.

Primary outcomes

  1. 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

    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 outcomes

  1. Urine metabolomic and proteomic profiles in KunQi Cohort

    Time frame: 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.

  2. Blood metabolomic and DNA profiles in KunQi Cohort

    Time frame: 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.

  3. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Xu, PhD.MD.

CONTACT

[email protected]

+8602164932829

Yihui Zhai

CONTACT

[email protected]

+8613916488230

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • Kunshan City Maternal and Child Health Hospital
  • Qidong City Maternal and Child Health Hospital

Registry information

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Aug 31, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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