Comparison of Transcutaneous or Laboratory Measurement of Bilirubin in the Newborn
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Comparison of transcutaneous bilirubin (skin color, TcB) and bilirubin measured in a blood sample (TsB)
研究概览
简要总结
Prospective comparison of measurement of bilirubin in jaundiced newborns by a transcutaneous device (bilirubinometer) and laboratory analysis of blood samples.
We hypothesise that correlation of the two measurements depend on bilirubin level, gestational age as well as postnatal age.
详细描述
Whenever a blood sample is drawn for measurement of bilirubin in a newborn, a transcutaneous measurement of skin yellow color will be made. Such measurements will also be included in all infants when a CRP-test (blood sample for C-reactive protein) has been ordered, as well as in connection with the routine blood sampling for metabolic screening. Only infants where parents have given written consent for their infant will be included in the study.
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
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborn infant admitted to normal newborn nursery
排除标准
- •Informed consent not obtained
结局指标
主要结局
Comparison of transcutaneous bilirubin (skin color, TcB) and bilirubin measured in a blood sample (TsB)
时间窗: 12 months
To have statistical strength for comparison of the two tests between 1500 and 2000 patients are needed
次要结局
- Differences in TcB measured at the forehead or at the sternum(12 months)