Trials / Not Yet Recruiting
Not Yet RecruitingNCT07382570
Natural Course of Congenital Hydronephrosis in Infants Aged 0-6 Months
Multicenter Prospective Cohort Study Protocol on the Natural Course of Congenital Hydronephrosis in Infants Aged 0-6 Months (3-Year Cycle)
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 330 (estimated)
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine · Academic / Other
- Sex
- All
- Age
- 0 Months – 6 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No Intervention: Observational Cohort | No intervention |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2028-03-01
- Completion
- 2028-11-30
- First posted
- 2026-02-03
- Last updated
- 2026-02-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07382570. Inclusion in this directory is not an endorsement.