BiliCam Clinical Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BiliCam, LLC
- 入组人数
- 203
- 试验地点
- 2
- 主要终点
- BCB - TSB Correlation
研究概览
简要总结
The goal of this study is to assess the accuracy of BiliCam, a non-invasive technology based on analysis of digital images obtained with an app installed on a commercial smartphone, in estimating total serum bilirubin levels in newborns. BiliCam estimated bilirubin levels will be compared to total serum bilirubin levels in up to 225 newborns.
详细描述
Jaundice, a yellowing of the skin and eyes caused by a build up of bilirubin in the blood, is a common problem in newborn infants. Measurement of total serum bilirubin (TSB) levels is used for clinical decision making. BiliCam is a non-invasive technology used to estimate TSB levels in newborns. With BiliCam, the user obtains digital images of a small portion of a newborn's skin using the BiliCam app installed on a commercial smartphone in a standardized manner. A color calibration card is placed on the baby's sternum to account for varying light conditions. Data on color levels in the photos are used to estimate a bilirubin level.
For the study, paired BiliCam estimated bilirubin (BCB) and TSB levels will be compared on a racially and ethnically diverse sample of newborns. Recruitment will continue until 225 newborns have completed the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 0 Hours 至 191 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborn born at ≥ 35 weeks gestation
- •Parent speaks and reads English
- •Parent provides written informed consent
排除标准
- •previous or ongoing treatment with phototherapy for hyperbilirubinemia
- •Medical or other complications that preclude completion of the study
结局指标
主要结局
BCB - TSB Correlation
时间窗: Newborns up to 192 hours old
Pearson correlation coefficient between paired BCB- TSB measurements
次要结局
- Slope of Regression Line(Newborns up to 192 hours old)
- Intercept of Regression Line(Newborns up to 192 hours old)