Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice in Newborns with High Melanin Content (Chicago)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Picterus AS
- 入组人数
- 250
- 试验地点
- 1
- 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 at the University of Chicago Medicine facilities (hospital and outreach clinics) to enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
详细描述
A cross-sectional conductive study at the University of Chicago Medicine facilities (hospital and outreach clinics) will be conducted to include a total of 250 newborns with a desired distribution of skin color according to Neomar's scale : skin color 1 and 2: 20%, skin color 3: 30% and skin color 4: 50%. Skin color may also be quantitatively assessed using a handheld spectrophotometer (CM-700d, Konica Minolta).
The Picterus Calibration Card will be placed on the chest of the newborn with the hole in the card placed over the infant's chest. A validated smartphone with Picterus JP will be used to collect digital images, which are analysed to calculate a Picterus bilirubin value.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 > 35 weeks.
- •Birth weight ≥ 1800 grams
- •Age 1 - 14 days
- •Infants requiring a TSB blood sample for clinically suspected jaundice as part of standard care
排除标准
- •Infants showing signs of inborn disease.
- •Infants with skin rash or other skin disease that affects the skin where measurements are performed.
- •Infants transferred to the pediatric ward for medical treatment.
- •Infants that have received phototherapy in the last 24 hours
研究组 & 干预措施
Enable high qualitative estimation of bilirubin levels in the blood of new-borns
There is only one arm in this study which is to enable high qualitative estimation of bilirubin levels in the blood of new-borns, independent of skin color, using Picterus JP.
干预措施: Picterus Jaundice Pro (JP) (Device)
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: 3-6 months
Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.
次要结局
- Correlate estimates of bilirubin levels obtained by Picterus JP with TSB, TcB and VA in newborns with high melanin content in the skin.(3-6 months)
- Determine the accuracy of Picterus JP in newborns with high melanin content in the skin.(3-6 months)
- Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin.(3-6months)