Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 342
- 试验地点
- 2
- 主要终点
- Correlation between bilirubin estimates by smartphone pictures and by blood samples
研究概览
简要总结
Neonatal jaundice is a common and most often harmless condition. However, when unrecognized it can be fatal or cause serious brain injury. Three quarters of these deaths are estimated to occur in the poorest regions of the world. The treatment of jaundice, phototherapy, is in most cases easy, low-cost and harmless. The crucial point in reducing the burden of disease is therefore to identify then children at risk. This results in the need for low-cost, reliable and easy-to-use diagnostic tools that can identify newborns with jaundice.
Based on previous research on the bio-optics of jaundiced newborn skin, a prototype of a smartphone application has been developed. This prototype will be evaluated in a clinical trial in two hospitals in Norway. A smartphone will be used to take picture of the skin of the newborn, and by using an algorithm an estimate of the bilirubin concentration is made. The results from these estimates will be compared to the bilirubin levels measured in standard blood samples, as well as the results from ordinary transcutaneous measurement devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 14 Days(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •born in St.Olavs hospital, Trondheim or in Akershus hospital, Oslo, Norway
- •born at term
- •normal birth weight
排除标准
- •in need of advanced medical treatment
结局指标
主要结局
Correlation between bilirubin estimates by smartphone pictures and by blood samples
时间窗: 5 minutes
Estimate of bilirubin levels from smartphone pictures, compared with bilirubin measurement in blood samples in a correlation study. Correlation will be expressed by Pearson correlation coefficient, r.
Correlation between bilirubin estimates by smartphone pictures and by transcutaneous measurements
时间窗: 5 minutes
Estimate of bilirubin levels from smartphone pictures, compared with bilirubin measurements from transcutaneous devices in a correlation study. Correlation will be expressed by Pearson correlation coefficient, r.
次要结局
未报告次要终点
