Urine and Ultrasound Screening for Kidney Disease in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 6
SponsorChildren's Hospital of Fudan University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All consecutive live newborn infants(regardless of physical condition)
Complete at least 3 years of follow-up
Disqualifiers
Declining the screening
Missing
Trial design
Design model
Single group
Treatments tested in this trial
Urine and Ultrasound Screening
Other interventionWhen 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.
Treatment groups
13,000 Participants
are divided into 1 treatment groupGroup A: Urine and Ultrasound ScreeningExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From baseline to the third or sixth year of the studySecondary outcomes
1
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.
Time frame
From baseline to the third or sixth year of the study2
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.
Time frame
From baseline to the third or sixth year of the study3
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.
Time frame
From baseline to the third or sixth year of the studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Fudan University
Lead sponsor
Kunshan City Maternal and Child Health Hospital
Collaborator
Qidong City Maternal and Child Health Hospital
Collaborator
Source ClinicalTrials.gov