Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Picterus AS
- 入组人数
- 284
- 试验地点
- 6
- 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
A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns in Surabaya.
详细描述
A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Airlangga University hospital and RSIA Kendangsari MERR in Surabaya.
This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in Indonesian newborns. 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 Hour 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants born with gestational age >31
- •Birth weight ≥ 1500g
- •Age 0 - ≤14 days
- •Consent obtained from the parents
排除标准
- •Infants born with congenital abnormalities;
- •Infants respiratory support;
- •Infants suffering from a condition that may alter the skin tissue circulatory system, such as sepsis and heart failure;
- •Infants who have received phototherapy in the last 24 hours.
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 Indonesian newborns.
次要结局
- 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 in from a smartphone application and bilirubin measurements in serum in newborn(1-2 minutes)
- Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns(5-10 minutes)