Validation of a Low-Cost, Point-of-Care Bilirubin Measurement to Diagnose Neonatal Jaundice and Monitor Phototherapy in Hospitals in Sub-Saharan Africa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- Device Accuracy
研究概览
简要总结
A team of researchers at Rice University in partnership with clinicians at Queen Elizabeth Central Hospital created BiliSpec, a low-cost battery-powered reader designed to immediately quantify serum bilirubin levels from a small drop of whole blood applied to a lateral flow strip. The simple and affordable BiliSpec system offers a faster and more cost-effective means to detect neonatal jaundice in under-resourced clinics and determine when phototherapy is needed. The goal of this study is to validate the accuracy of the BiliSpec device in measuring bilirubin levels in neonates relative to the laboratory spectrophotometric bilirubinometer and transcutaneous bilirubinometer measurements.
详细描述
This study will validate the accuracy of the BiliSpec device in measuring bilirubin levels in neonates relative to a laboratory spectrophotometric bilirubinometer (Reichert UNISTAT® Bilirubinometer) and transcutaneous bilirubinometer measurements.
This study will enroll up to 500 neonates at Queen Elizabeth Central Hospital and Kamuzu Central Hospital each, for a total of up to 1000 neonates, at risk for jaundice based on clinical signs and symptoms or undergoing phototherapy for treatment of jaundice. During the pilot study, 100 participants were evaluated and 147 samples total were collected. However only 7 samples collected were over 20 mg/dL. In addition to confirming the accuracy of BiliSpec in this validation study, enough samples of clinically high bilirubin concentrations (>20mg/dL) will need to be collected to ensure the device functions properly over the intended dynamic range (0-35 mg/dL). To accomplish this, data from up to 500 participants at each location will be collected.
Informed consent will be requested from the parents of all eligible babies on the ward for this study. If the guardian does not consent, the patient's bilirubin levels will be assessed using the standard of care on the ward.
During the study, the following steps will be taken:
The trained study nurse will assess the subject for clinical complications before performing the necessary heel prick blood draw.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is currently being treated at Queen Elizabeth Central Hospital or Kamuzu Central Hospital in the neonatal ward.
- •The patient is less than 28 days old (neonate).
- •The patient is deemed to be at risk for jaundice or the patient is undergoing blue light phototherapy for treatment of jaundice.
- •The patient's parent or guardian has provided informed consent for their child to participate.
排除标准
- •Parent or guardian is unable or unwilling to provide informed consent.
- •The patient is unable to receive a blood draw/heel stick as determined by their clinician.
结局指标
主要结局
Device Accuracy
时间窗: Total duration of hospital stay while inclusion criteria are met (<10 minutes per sample)
Bilirubin content measured by the BiliSpec device compared against the Reichert UNISTAT laboratory spectophotometric bilirubinometer as well as a transcutaneous bilirubinometer.
次要结局
未报告次要终点