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Protocol for a 3-Year Multicenter Prospective Cohort Study on the Natural History of Congenital Hydronephrosis in Infants Aged 0–6 Months

Protocol for a 3-Year Multicenter Prospective Cohort Study on the Natural History of Congenital Hydronephrosis in Infants Aged 0–6 Months

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121034
Enrollment
Unknown
Registered
2026-03-24
Start date
2026-03-25
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital hydronephrosis

Interventions

Case group:None

Sponsors

Children's Hospital,Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: 1. Diagnostic Criteria: Confirmed diagnosis of congenital hydronephrosis via abdominal ultrasound, meeting the criteria for urinary tract dilation grading (Grades I–III), defined as a fetal renal pelvis anteroposterior diameter of >= 4 mm or a postnatal renal pelvis anteroposterior diameter of >= 7 mm, or accompanied by symptoms such as calyceal dilation or changes in renal parenchyma. 2. Feasibility of Follow-up: The guardian commits to cooperating with a 3-year follow-up, is able to attend regular examinations at the research center, and has stable contact information. 3. Informed Consent: The legal guardian voluntarily participates in this study and signs a written informed consent form.

Exclusion criteria

Exclusion criteria: 1.Presence of other severe congenital anomalies, such as congenital heart disease, biliary atresia, spina bifida, or other conditions that may interfere with follow-up or prognosis evaluation. 2.Secondary hydronephrosis caused by acquired factors including urinary tract tumors, calculi, trauma, or confirmed genetic metabolic diseases. 3.Prior intervention before enrollment, including hydronephrosis-related surgical treatment (e.g., pyeloplasty) or medical intervention (e.g., long-term diuretic use). 4.Severe underlying diseases, such as severe infection, respiratory failure, renal failure (glomerular filtration rate < 30 mL/min/1.73 m²), or other conditions incompatible with long-term follow-up. 5.Legal guardian is unable to understand study procedures due to mental illness, cognitive impairment, or refuses to comply with follow-up and data collection.

Design outcomes

Primary

MeasureTime frame
Remission rate of hydronephrosis;

Secondary

MeasureTime frame
Incidence of urinary tract infection (UTI);Intervention rate;Progression rate of hydronephrosis;renal function;

Countries

China

Contacts

Public ContactGuangjie Chen

Children's Hospital,Zhejiang University School of Medicine

dr.chenguangjie@zju.edu.cn+86 571 8667 0890

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 4, 2026