A mHealth Application as a Screening Tool for Neonatal Jaundice in Filipino Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Picterus AS
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- validate the reliability of the Picterus mHealth application as a screening tool for neonatal jaundice in Filipino neonates
研究概览
简要总结
The purpose of the study is to test the reliability of the Picterus smartphone application in Filipino neonates. A descriptive cross-sectional study will be the method to understand the correlation of the modalities and to determine the reliability of the application
详细描述
The purpose of the study is to test the reliability of the Picterus smartphone application.
The study is designed for Filipino neonates, but implemented in other LMIC. The participants include newborns with or without jaundice, Gestational age >37 weeks, Age0-14days, Weight >2500 gram and absence of congenital malformations. Demographic data of the neonates will be collected together with all the performed tests and it will be stored in a secured system. Blood will be drawn and measure the bilirubin level of the neonates in a standard clinical routine and will be compared to the estimated bilirubin performed with the Picterus smartphone application.
A descriptive cross-sectional study will be the method to understand the correlation of the modalities and to determine the reliability of the application.
It will provide an answer to whether the Picterus smartphone application is reliable to other populations, especially to darker skin and with high melanin content such as Filipino neonates.
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
- •Newborns with or without jaundice
- •Gestational age ≥ 37 weeks
- •Age 0 - 14 days
- •Weight 2500 to 4500 grams
- •Absence of congenital malformations
排除标准
- •Newborns with life-threatening conditions or significant illness
- •Newborns diagnosed with inborn errors of metabolism
- •Jaundiced newborns that have undergone phototherapy before screening
结局指标
主要结局
validate the reliability of the Picterus mHealth application as a screening tool for neonatal jaundice in Filipino neonates
时间窗: 5-10 minutes
Validation of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.
次要结局
- correlation between the estimated level of bilirubin detected by the Picterus mHealth application and those obtained using visual Kramer scale in Filipino neonates.(5 minutes)
- correlation between the estimated levels of bilirubin detected by the Picterus mHealth application and bilirubin serum levels in Filipino neonates(1-2 hours)
- correlation between the estimated level of bilirubin detected by the Picterus mHealth application and transcutaneous bilirubinometer results in Filipino neonates.(5-10 minutes)
- sensitivity, specificity, positive and negative predictive value between estimated bilirubin level of the digital images, Kramer examination and TcB.(5 months)