NCT05894122招募中不适用
Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®) in the Context of Metabolic Diseases and, in Particular, Pediatric Monitoring of Phenylketonuria
University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年12月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Comparison of phenylalanine concentrations
研究概览
简要总结
The aim is to demonstrate a new application for a blood collection device. This device is already widely used in pharmacology. It is not currently used for metabolic diseases.
Its ease of use enables repeated sampling at home. What's more, the device can be sent by post, making it ideally suited to the needs of this cohort of children, whose phenylalanine levels need to be monitored very regularly.
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
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3 months to 18 years
- •suffering from phenylketonuria or hyperphenylalaninemia
- •who have had a capillary and blood test including a phenylalanine assay at CHUGA
- •Whose parents or legal guardians are affiliated to the social security system.
- •For whom parents or legal guardians have not objected to the MitrAlanine study.
排除标准
- •Parents or legal guardians opposed to the MitrAlanine study
结局指标
主要结局
Comparison of phenylalanine concentrations
时间窗: Day 1
Comparison of phenylalanine concentrations in the new device with those in the current device (blotter).
次要结局
- Ease of use of research device(Day 1)
- sample conformity(Day 1)
- comparison of concentrations of tyrosin(Day 1)
- comparison of concentrations of total leucin(Day 1)
- comparison of concentrations of methionin(Day 1)
研究者
研究点 (1)
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