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

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.

NCT Number	NCT07382570
Lead Sponsor	The Children's Hospital of Zhejiang University School of Medicine
Conditions	Congenital Hydronephrosis, UTD Grading System, Natural Progression, Pediatric
Enrollment	330 participants
Start Date	2026-03-01
Primary Completion	2028-03-01 (estimated)
Study Completion	2028-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-02-11