Multicenter Prospective Cohort Study Protocol on the Natural Course of Congenital Hydronephrosis in Infants Aged 0-6 Months (3-Year Cycle)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Hydronephrosis Resolution Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnostic Criteria: Congenital hydronephrosis is diagnosed by abdominal ultrasound examination and meets the UTD grading system criteria (Grades I-III). This is defined as an anterior-posterior renal pelvis diameter (APD) ≥4 mm during the fetal period or ≥7 mm after birth, or accompanied by calyceal dilation, renal parenchymal changes, and other manifestations.
- •Informed Consent: The legal guardian voluntarily agrees to participate in the study and provides written informed consent.
- •Follow-up Feasibility: The guardian commits to cooperating with the complete 3-year follow-up period, including attending regular examinations at the research center, and maintains stable contact information.
排除标准
- •Presence of other severe congenital malformations that may affect follow-up or prognosis assessment, such as congenital heart disease, biliary atresia, spina bifida, etc.
- •Secondary hydronephrosis caused by acquired factors (e.g., urinary system tumors, stones, trauma) or well-defined genetic metabolic diseases.
- •Having received interventional treatments prior to enrollment, such as surgical procedures related to hydronephrosis (e.g., pyeloplasty) or pharmacological interventions (e.g., long-term use of diuretics).
- •Severe underlying diseases that preclude tolerance for long-term follow-up, such as severe infections, respiratory failure, or renal failure (e.g., glomerular filtration rate < 30 ml/min/1.73m²).
- •Inability of the legal guardian to cooperate due to mental illness, cognitive impairment, or refusal to comply with follow-up schedules and data collection requirements.
研究组 & 干预措施
UTDⅠ
干预措施: No Intervention: Observational Cohort (Other)
UTD II
干预措施: No Intervention: Observational Cohort (Other)
UTD III
干预措施: No Intervention: Observational Cohort (Other)
结局指标
主要结局
Hydronephrosis Resolution Rate
时间窗: During the follow-up period (3 years)
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.
次要结局
- Rate of Hydronephrosis Progression (UTD Classification)(During the follow-up period (3 years))
- Rate of Renal Parenchymal Thinning(During the follow-up period (3 years))
- Incidence of Urinary Tract Infections (UTI)(During the follow-up period (3 years))
- Change in Estimated Glomerular Filtration Rate (eGFR)(During the follow-up period (3 years))
- Change in Weight-for-age Z-score(During the follow-up period (3 years))
- Change in Height-for-age Z-score(During the follow-up period (3 years))
研究者
Guangjie Chen
Chief Physician
The Children's Hospital of Zhejiang University School of Medicine