Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Picterus AS
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns
研究概览
简要总结
The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals:
- Demonstrate that Picterus system performs accurately in Indonesian newborns
- Ensure that Picterus is in line with users' needs in Indonesia
详细描述
The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals:
- Demonstrate that Picterus system performs accurately in Indonesian newborns
- Ensure that Picterus is in line with users' needs in Indonesia
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 ≥37 weeks Birth weight ≥2000g and ≤4500g Age 1 - 14 days
排除标准
- •Infants transferred to the pediatric 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
Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns
时间窗: 6 months
Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns using Picterus JP.
次要结局
- Correlation with TcB(5-10 minutes)
- Picterus JP accuracy in Indonesian newborn(6 months)
- Correlation with Tsb and TcB(1-2 hours)