Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Picterus AS
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Smartphone application sensitivity (bilirubin levels on newborns)
研究概览
简要总结
The general objective of this study is to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at HICH Mbarara.
详细描述
The general objective of this study is to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at HICH Mbarara.
The specific objectives for this study are:
To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns with varying degree of jaundice To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice
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
- 24 Hours 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 ≥2000g and ≤4500g
- •Age 1 - 14 days
- •Infants requiring a blood sample (newborn screening / clinically suspected jaundice)
排除标准
- •Infants transferred to the paediatric ward for advanced treatment.
- •Infants with a skin rash or other disease that affects the skin where measurements are performed.
- •Infants that receive or have received phototherapy in the last 24 hours.
- •Infants with an inborn disease
结局指标
主要结局
Smartphone application sensitivity (bilirubin levels on newborns)
时间窗: 5 minutes
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
次要结局
- Smartphone application sensitivity (bilirubin levels on newborns with high melanin content) in the skin.(5 minutes)