NCT00895765Unknown不适用
Part 1 The Outcome of Children With Melamine-Related-Calculus
Zhejiang University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2008年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- The calculus measured by sonography
研究概览
简要总结
The purpose of this study is to investigate the lesions, clinical features and outcome in young children with melamine-related-calculus.
详细描述
- To investigate the outcome of melamine-related-calculus.
- The change of calculus.
- The change of obstruction features,including hydronephrosis and ureterectasia.
- The change of the urinalysis.
- To investigate the change of renal function in children with melamine-related-calculus during the follow up.
- Creatinine, urea and uric acid.
- α and β2 microglobulin.
- To analysis the factors might be associated with the outcome.
- The characteristics of patients: age, gender, and so on.
- The characteristics of calculus: location, size, and so on.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children with melamine-related-calculus: with a history of melamine contaminated products
- •the parents leave the detailed information for contact and willing to be recalled
排除标准
- •children with other congenital renal abnormality
- •children with hypercalciuria
- •children have abnormality of parathyroid gland
结局指标
主要结局
The calculus measured by sonography
时间窗: at 1, 3, 6 and 12 months
次要结局
- Renal function (e.g., creatinine, microglobulin)(at 1, 3, 6 and 12 months)
研究者
研究点 (1)
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