Clinical Validation of the Screening Tool Picterus Jaundice Pro to Assess Neonatal Jaundice Using Different Types of Smartphones
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Picterus AS
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- jaundice screening
研究概览
简要总结
The overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of Picterus JP on all smartphones.
详细描述
The overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of Picterus JP on all smartphones.
Picterus JP bilirubin estimates from a Samsung S7 will be compared with three smartphones with different camera types and a TcB measurement The clinical outcomes will be compared to our camera validation systems. Skin color measurements using a spectrophotometer will be used for technical optimization of the camera validation system
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
- 是
入选标准
- •Infants born with gestational age > 37 weeks.
- •Birth weight ≥ 2500 grams
- •Age 1 - 14 days
排除标准
- •Infants showing signs of inborn disease.
- •Infants with skin rash or other skin disease that affects the skin where measurements are performed.
- •Infants transferred to the pediatric ward for medical treatment.
- •Infants that have received phototherapy in the last 24 hours
结局指标
主要结局
jaundice screening
时间窗: 6 months
reproducible jaundice screening independent of smartphone used
次要结局
未报告次要终点