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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UTDⅠ |
| ||
| UTD II |
| ||
| UTD III |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention: Observational Cohort | Other | No intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Hydronephrosis Resolution Rate | 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. | During the follow-up period (3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Hydronephrosis Progression (UTD Classification) | Percentage of participants with an increase of ≥1 grade in the UTD classification compared to the baseline. | During the follow-up period (3 years) |
| Rate of Renal Parenchymal Thinning |
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Inclusion Criteria:
Exclusion Criteria:
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Infants diagnosed with congenital hydronephrosis by abdominal ultrasound within 0-6 months after birth, meeting the UTD classification criteria (Grades I-III).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guangjie Chen | Contact | +86 13868175229 | dr.chenguangjie@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's hospital, Zhejiang Univeristy School of Medicine | Hangzhou | Zhejiang | 310052 | China |
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Percentage of participants with a decrease of ≥2mm in renal parenchymal thickness from baseline measured by ultrasound.
| During the follow-up period (3 years) |
| Incidence of Urinary Tract Infections (UTI) | The number of symptomatic UTI episodes per participant, characterized by a positive urine culture | During the follow-up period (3 years) |
| Change in Estimated Glomerular Filtration Rate (eGFR) | The mean change from baseline in eGFR levels to assess the trend of renal function over time. | During the follow-up period (3 years) |
| Change in Weight-for-age Z-score | The Z-scores are calculated based on the WHO Child Growth Standards to assess the child's weight development status. | During the follow-up period (3 years) |
| Change in Height-for-age Z-score | The Z-scores are calculated based on the WHO Child Growth Standards to assess the child's linear growth development status. | During the follow-up period (3 years) |