Wireless Irradiance SEnsors During Neonatal Phototherapy: The WISE Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Light Intensity
研究概览
简要总结
Bilisensors are devices designed to measure the cumulative dose of phototherapy administered to neonates undergoing treatment for hyperbilirubinemia. The current standard of care typically involves intermittent spot measurements once a day using a handheld dosimeter that may give variable estimations. In contrast, bilisensors may enable continuous, real-time monitoring of light exposure, helping to know the total phototherapy dose received by the infant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be admitted to the Montreal Children's Hospital (MCH) Neonatal Intensive Care Unit (NICU)
- •Under phototherapy as clinically indicated
- •Diagnosis of indirect hyperbilirubinemia
- •Weight of >1000g at time of enrollment
排除标准
- •Any abnormal skin conditions (example: extreme dryness, desquamation, congenital skin disorders, etc.)
- •Diagnosis of direct hyperbilirubinemia
- •Weight of <1000g at time of enrollment
- •Any baby or family deemed ineligible (ex. too much stress, too unstable) by the clinical care team
研究组 & 干预措施
Term Infant
Weighing > 2500g at recruitment.
Extremely Preterm Infant
Weighing < 1500g at recruitment.
Late Preterm Infant
Weighing between between 1500g and 2500g at recruitment.
结局指标
主要结局
Light Intensity
时间窗: 3 Hours
Comparison of intensity (µW/cm\^2) data between the investigational device and gold-standard Light meter at 3 time points: start, 1.5 h and end.
次要结局
- Cumulative Dose(3 Hours)
- Data Transmission & Gaps(2 Months)
研究者
Guilherme Sant'Anna, MD
Neonatologist
McGill University Health Centre/Research Institute of the McGill University Health Centre