临床试验/NCT02445755

NCT02445755已完成不适用

Transcutaneous Bilirubinometry in Neonates With the Bilicare System

Stanford University0 个研究点目标入组 113 人开始时间: 2014年6月最近更新: 2015年6月4日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Stanford University
入组人数: 113
主要终点: In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to test the performance of a new transcutaneous ("measured through skin") bilirubin device (BiliCare™) to measure bilirubin levels. The investigators plan to evaluate the clinical performance of this device as a point of care test. If the investigators can validate the BiliCare™ with bilirubin from your baby's blood they could verify a non-invasive alternative for measuring bilirubin.

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: 35 Weeks 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Parental informed consent
•Male and female newborns with a GA ≥ 35 wks
•Enrollment at age > 6 hrs until neonatal discharge
•Pre-phototherapy

排除标准

•Infants requiring respiratory assistance (such as mechanical ventilation)
•Severe or life-threatening congenital anomalies
•Hematomas at the point of measurement on both ears
•Neonates undergone blood transfusion

结局指标

主要结局

In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours.

时间窗: 12 to 48 hours

次要结局

未报告次要终点

研究者

发起方

Stanford University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Vinod K. Bhutani

Stanford University

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