Transcutaneous Bilirubinometry in Neonatal Hyperbilirubinemia During and After Phototherapy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- blood draws
研究概览
简要总结
A randomized Controlled trial comparing the use of transcutaneous bilirubinometry to serum bilirubin measurements (via blooddraws = standard care) in neonates born after a gestational age > 32 weeks and < 15 days of age treated with Phototherapy for neonatal hyperbilrubinemia.
详细描述
A randomized Controlled trial comparing the use of transcutaneous bilirubinometry to serum bilirubin measurements (via blooddraws = standard care) in neonates born after a gestational age > 32 weeks and < 15 days of age treated with Phototherapy for neonatal hyperbilrubinemia. Main outcome measurement is the number of blooddraws for measurement of bilirubin. Secondary outcome measurements are duration of phototherapy and hospitalisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates with indication for phototherapy for treatment of hyperbilirubinemia
排除标准
- •skinlesions located on the sternum interfering with transcutaneous measurement
- •exchange transfusion
结局指标
主要结局
blood draws
时间窗: during hospitalisation with a maximum of 14 days
number of blood draws from the start of phototherapy for measurement of serum bilirubin
次要结局
- hospitalisation(3 months)
- phototherapy duration(during hospitalisation with a maximum of 14 days)
研究者
Jolita Bekhof
MD PhD Principal Investigator
Princess Amalia Children's Clinic