Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Picterus AS
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Enable high qualitative estimation of bilirubin levels in newborns, independent of skin color, using Picterus JP
研究概览
简要总结
A cross-sectional study at the Södersjukehuset facility (Stockholm, Sweden) collect data of newborns from a population with Neomar scale type 4 to adjust the algorithm of Picterus JP
详细描述
To adjust Picterus JP to work in newborns with more pigmented skin, the investigators will collect a data set at Sachsska barnsjukhuset Södersjukhuset, Stockholm Sweden from 150 newborns with dark skins using Picterus JP, TcB, skin measurements from a spectrometer, visual assessment, and total serum bilirubin (TSB) levels. As a control, newborns with Neomar scale 1-3 will be included.
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
- •Birth weight ≥ 2500g
- •Age 1 - 14 days
- •Will have a blood sample performed, either for clinically suspected jaundice or newborn screening sample
排除标准
- •Infants showing signs of inborn disease
- •Infants transferred to pediatric ward for treatment
- •Infants that have received phototherapy
结局指标
主要结局
Enable high qualitative estimation of bilirubin levels in newborns, independent of skin color, using Picterus JP
时间窗: 6 months
Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with Neomar neonatal skin color scale type 4 (with type 1 being lower-melanin level and Type 4 being higher-melanin level)
次要结局
- Comparison of Picterus-generated estimate with TsB(1-2 hours)
- Comparison of Picterus-generated estimate with TcB(5-10min)
- Comparison of Picterus-generated estimate with visual assessment.(5-10min)