The Use of Near-Infrared Fluorescence Cholangiography With Indocyanine Green (ICG) in the Work Up of Neonatal Cholestasis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The number and accuracy of ICG fluorescence in the diagnosis of biliary atresia
研究概览
简要总结
In infants that present with findings concerning for biliary atresia, along with other cholestatic work up which is standard, they will receive a one-time intravenous (IV) dose of Indocyanine Green (ICG). The infant's diapers will subsequently be examined for presence of the ICG, and if present, suggests bile flow. This was described as 97% accurate for assessing biliary patency and we would like to perform a similar study to assess biliary patency in the work up of neonatal cholestasis.
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
- 2 Weeks 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants admitted to the hospital (no matter their age, sex, race/ethnicity) who a hepatologist deems warrants inpatient work up of neonatal cholestasis suspected to be due to biliary atresia.
排除标准
- •Infants that a hepatologist has not deemed to warrant inpatient admission for work up of neonatal cholestasis suspected to be due to biliary atresia.
- •Infants that are managed in the outpatient setting
- •Non-cholestatic infants
- •Patient who are on TPN AND NPO for reasons other than temporary imaging or surgical requirements
- •Infant with a history of bowel resection or other surgical procedures known to introduce blood into the gastrointestinal tract.
研究组 & 干预措施
Cholestatic infants
infants that are cholestatic needing further work up for biliary atresia
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
The number and accuracy of ICG fluorescence in the diagnosis of biliary atresia
时间窗: Within 72 hours
Measuring stool fluorescence using near infrared imaging
次要结局
未报告次要终点
研究者
Sam Hagman
Fellow
University of Alabama at Birmingham