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NCT07382570

Natural Course of Congenital Hydronephrosis in Infants Aged 0-6 Months

Sponsor: The Children's Hospital of Zhejiang University School of Medicine

View on ClinicalTrials.gov

Summary

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.

Official title: Multicenter Prospective Cohort Study Protocol on the Natural Course of Congenital Hydronephrosis in Infants Aged 0-6 Months (3-Year Cycle)

Key Details

Gender

All

Age Range

0 Months - 6 Months

Study Type

OBSERVATIONAL

Enrollment

330

Start Date

2026-03-01

Completion Date

2028-11-30

Last Updated

2026-02-11

Healthy Volunteers

No

Interventions

OTHER

No Intervention: Observational Cohort

No intervention

Locations (1)

Children's hospital, Zhejiang Univeristy School of Medicine

Hangzhou, Zhejiang, China