Children's hospital, Zhejiang Univeristy School of Medicine
Hangzhou, Zhejiang, 310052, China
NCT Number: NCT07382570
This project aims to systematically delineate the natural progression of congenital hydronephrosis diagnosed within the critical window of 0-6 months through a prospective, multicenter, observational cohort study. The focus will be on analyzing the resolution rates, progression rates, and influencing factors of hydronephrosis of varying severities based on the UTD grading system.
Congenital hydronephrosis is one of the most common congenital urinary system abnormalities in children, with a high prenatal detection rate. However, its postnatal natural course is highly heterogeneous, leading to significant controversy in clinical management regarding follow-up intensity and intervention timing. Currently, there is a lack of prospective, large-sample, multicenter natural history data in China. By establishing a standardized follow-up system and collecting high-quality clinical and imaging data, this study aims to provide high-level evidence-based medical support for developing individualized and precise clinical management strategies, thereby reducing unnecessary interventions and delayed treatment. Consequently, conducting this multicenter study holds significant clinical and scientific value.
Trial opening soon.
Get Notified0 month–6 month
All sexes
Observational
Hangzhou, Zhejiang, 310052, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention
Time frame: During the follow-up period (3 years)
During the follow-up period (3 years), the child's hydronephrosis decreased from the UTD grade at enrollment to grade I or below, and this status persisted for ≥6 months.
Time frame: During the follow-up period (3 years)
Percentage of participants with an increase of ≥1 grade in the UTD classification compared to the baseline.
Time frame: During the follow-up period (3 years)
Percentage of participants with a decrease of ≥2mm in renal parenchymal thickness from baseline measured by ultrasound.
Time frame: During the follow-up period (3 years)
The number of symptomatic UTI episodes per participant, characterized by a positive urine culture
Time frame: During the follow-up period (3 years)
The mean change from baseline in eGFR levels to assess the trend of renal function over time.
Time frame: During the follow-up period (3 years)
The Z-scores are calculated based on the WHO Child Growth Standards to assess the child's weight development status.
Time frame: During the follow-up period (3 years)
The Z-scores are calculated based on the WHO Child Growth Standards to assess the child's linear growth development status.
Contact information is provided by the study sponsor or research team.
The Children's Hospital of Zhejiang University School of Medicine
Other
Multicenter Prospective Cohort Study Protocol on the Natural Course of Congenital Hydronephrosis in Infants Aged 0-6 Months (3-Year Cycle)
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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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