NCT04831723已完成不适用
NEWBIE Validate: Feasibility of a New Test to Measure Glucose in Newborn Blood Spots (NBS)
Royal Devon and Exeter NHS Foundation Trust4 个研究点 分布在 1 个国家目标入组 10,784 人开始时间: 2021年7月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10,784
- 试验地点
- 4
- 主要终点
- Normal range of capillary blood glucose in newborns at day 5 of life
研究概览
简要总结
The aim of this feasibility laboratory study is to evaluate whether the laboratory testing pathway for glucose screening in newborn blood spots (NBS) can be done at scale, and that the glucose test has a carefully established cut-off to define what level glucose is abnormal at day 5 of life.
The investigators aim to run this feasibility study for a period of 6 to 12 months to fully embed and test the process. This will equate to assessing glucose levels in approximately 10,000 NBS samples. The results from this study will inform a future large scale prospective screening study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Babies having a routine NBS screening test.
- •Routine maternity care team within the area served by the Portsmouth regional screening laboratory (NHS Trusts within Hampshire, Dorset & parts of Wiltshire)
排除标准
- •Parent decides to opt-out of the blood glucose test feasibility study.
结局指标
主要结局
Normal range of capillary blood glucose in newborns at day 5 of life
时间窗: 12 months
次要结局
- Validation of laboratory procedures(12 months)
研究者
研究点 (4)
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