Intermountain Inpatient Bilirubin Decision Accuracy Study Using Smartphone-based Measurements by Picterus Jaundice Pro
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Picterus AS
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Enable high qualitative estimation of bilirubin levels in the blood of term and preterm newborns undergoing phototherapy using Picterus JP.
研究概览
简要总结
The goal of this project is to evaluate the performance of Picterus Jaundice Pro in an American population, including preterm and term newborns and pre- and post- phototherapy.
详细描述
The purpose of this study is to compare serum bilirubin levels with non-invasive bilirubin measurements in neonates during the first 12 to 192 hours of life using the "Picterus Jaundice Pro" smartphone application with a proprietary calibration card placed over the neonate's sternum. We will also validate the accuracy of Picterus Jaundice Pro bilirubin measurements before and after phototherapy treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Hours 至 192 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •the patient is free of skin rash, bruising, or other medical conditions that can interfere with transcutaneous measurement
- •(preterm) < = 35 weeks gestational age
- •(term) > 35 weeks gestational age
- •the patient has not been excluded by PI discretion.
排除标准
- •Neonates will be excluded from participation if all four inclusion criteria listed above are not met.
结局指标
主要结局
Enable high qualitative estimation of bilirubin levels in the blood of term and preterm newborns undergoing phototherapy using Picterus JP.
时间窗: 2 months
Evaluate Picterus JP to screen for neonatal jaundice in term and preterm newborns undergoing phototherapy and use the results to improve the analysis algorithm for this population
次要结局
- Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies without phototherapy.(2 hours)
- Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies who have received phototherapy.(2 hours)
- Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies without phototherapy.(2 hours)
- Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies who have received phototherapy.(2 hours)