Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population at Dhulikhel Hospital, Kathmandu University Hospital.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Picterus AS
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
研究概览
简要总结
This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Dhulikhel Hospital, Kathmandu Nepal.
详细描述
This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in 200 newborns at Dhulikhel Hospital, Kathmandu Nepal. The Picterus Calibration Card was placed on the chest of the newborn with the hole in the card placed over the infant's sternum. A validated smartphone with Picterus JP was used to collect digital images.
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
- 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 ≥35 weeks
- •Birth weight ≥ 1750g
- •Age 1 - ≤14 days
- •Infants that will have a blood sample draw
排除标准
- •Infants in the need for respiratory support
- •Infants with conditions that could compromise skin circulation, as sepsis, heart failure
- •Infants that have received phototherapy
结局指标
主要结局
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
时间窗: 5-10 minutes
Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns at Dhulikhel Hospital, Kathmandu Nepal.
次要结局
- correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn(1-2 hours)
- correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns(5-10 minutes)
- Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns(5-10 minutes)
研究者
Anders Aune
Chief medical officer
Picterus AS