Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children.
Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children. Is it Useful for Diagnosis and Follow up?
研究概览
研究类型
阶段
- 不适用
联系人和位置
学习地点
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Strasbourg、法国、67098
- Service de Chirurgie Pédiatrique - Hôpital de Hautepierre- CHRU Strasbourg
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- child of 30 days old or less
- unilateral or bilateral hydronephrosis (pelvis > 5mm )
Exclusion Criteria:
- complex uropathy
- diuretic administration 6 hours prior to ultrasonography or scintigraphy
- oral feeding trouble
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Ultrasonography sensibilized by oral hydratation
Ultrasonography before, 30 min and 90 min following hydratation.
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Before, 30 min and 90 min following oral hydration
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care
大体时间：V2 (Age of 6 months)
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The primary outcome measure is a composite outcome measure consisting of multiple measures. Indeed, the treating surgeon will make a decision (ie to operate or not) upon the clinical exam, ultrasonography with oral hydratation and scintigraphy results. The independent surgeon will only be given data from the clinical exam and the ultrasonography. For ultrasonography, the following parameters will be measured: cortical thickness, anteroposterior renal pelvis diameter, calyx diameter, kidney echogenicity, kidney size. The measures will be done before, 30 min and 90 min following oral hydration. For scintigraphy, the relative kidney function, T1/2, Tmax and NORA will be analyzed. The result will be reported as a single value, ie:
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V2 (Age of 6 months)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care
大体时间：Between V0 (age: 30 days ) and V2 (age: 6 months)
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The secondary outcome measure is a composite outcome measure consisting of multiple measures. Indeed, the treating surgeon will make a decision (ie to operate or not) upon the clinical exam, ultrasonography with oral hydration and scintigraphy results. The independent surgeon will only be given data from the clinical exam and the ultrasonography with oral hydration, he will make a decision aposteriori. For ultrasonography, the following parameters will be measured: cortical thickness, anteroposterior renal pelvis diameter, calyx diameter, kidney echogenicity, kidney size. The measures will be done before, 30 min and 90 min following oral hydration. For scintigraphy, the relative kidney function, T1/2, Tmax and NORA will be analyzed. The result will be reported as a single value, ie:
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Between V0 (age: 30 days ) and V2 (age: 6 months)
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合作者和调查者
调查人员
- 首席研究员：Isabelle LACREUSE, MD、Hôpitaux Universitaires de Strasbourg
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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