NCT05623553已完成不适用
Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Picterus AS
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Enable high qualitative estimation of bilirubin levels in the blood of newborns using Picterus JP
研究概览
简要总结
This corss-sectional study aims to test the performance and accuracy of the Picterus JP screening device in newborns with different skin types.
详细描述
A descriptive cross-sectional study among 174 newborns was carried out at Hospital Materno-Infantil de Irapuato in Mexico during July and August 2018.
The Picterus Calibration Card will be 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 will be 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
- 0 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy newborns with or without signs of jaundice
- •Gestational age >35 weeks
- •Age 0-14 days
- •Birth weight > 1500 g.
- •Parents acceptance of their children to participate in the study.
- •Newborn needing a blood test
排除标准
- •Newborns showing signs or with diagnosis of inborn diseases
- •Newborn transferred to pediatric ward for any treatment
- •Newborns who had received phototherapy.
结局指标
主要结局
Enable high qualitative estimation of bilirubin levels in the blood of newborns using Picterus JP
时间窗: 6 months
Evaluate of smartphone-based diagnostic tool (Picterus JP) for neonatal jaundice in newborns.
次要结局
- Correlation with visual assessment(5-10 minutes)
- Correlation with TsB(1-2 hours)
- Correlation with TcB(5-10 minutes)
研究者
研究点 (2)
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