Implementation of a Transcutaneous Bilirubinometer in Jaundiced Newborns: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 430
- 试验地点
- 2
- 主要终点
- Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy).
研究概览
简要总结
Neonatal jaundice, caused by hyperbilirubinemia, is frequently seen in healthy newborns. Assessment of the degree of jaundice is usually done visually,and if necessary serum bilirubin is investigated in a blood sample. The visual assessment is subjective and can alternatively be replaced by transcutaneous measurement.The transcutaneous bilirubinometer is a validated measurement-tool, which provides us with an estimated serum bilirubin-concentration. Little is known about the effect of the actual use of a bilirubinometer on the quality of care. Further evidence is needed to evaluate whether transcutaneous bilirubin measurements improve clinical outcome (use of blood tests, phototherapy and exchange transfusion), shorten length of stay and reduce costs. Therefore we aim to perform a Randomized controlled trial to evaluate the cost-effectiveness of implementing the use of a transcutaneous bilirubinometer in jaundiced neonates, a gestational age of 32 weeks. The assessment of jaundice by use of a transcutaneous bilirubinometer is compared to visual assessment of jaundice
详细描述
Rationale:
Neonatal jaundice, caused by hyperbilirubinemia, is frequently seen in healthy newborns. Severe hyperbilirubinemia can cause bilirubin encephalopathy (kernicterus). Assessment of the degree of jaundice is usually done visually,and if necessary serum bilirubin is investigated in a blood sample. The visual assessment is subjective and can alternatively be replaced by transcutaneous measurement.The transcutaneous bilirubinometer is a validated measurement-tool, which provides us with an estimated serum bilirubin-concentration. Little is known about the effect of the actual use of a bilirubinometer on the quality of care. Further evidence is needed to evaluate whether transcutaneous bilirubin measurements improve clinical outcome (use of blood tests, phototherapy and exchange transfusion), shorten length of stay and reduce costs.
Objective:
To evaluate the cost-effectiveness of implementing the use of a transcutaneous bilirubinometer in jaundiced neonates.
Study design:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 24 Hours 至 8 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All newborns at the pediatric- and maternity-ward with visible jaundice.
- •Gestational age of 32 weeks or more.
- •Older than 24 hours.
- •Younger than 8 days.
排除标准
- •Neonatal jaundice within 24 hours or after 8 days
- •Hemolysis present based on maternal history (for example irregular erythrocyte antibodies)
- •Bilirubin encephalopathy
- •Newborns during/after phototherapy
- •Large congenital anomaly at forehead/sternum
- •Serum bilirubin-value is already known before admission to the pediatric ward;those newborns are to be admitted because the serum bilirubin-level has reached the phototherapy or exchange transfusion limit.
结局指标
主要结局
Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy).
时间窗: up to 1 year
次要结局
- Number of Patients With Serum Bilirubin-values Above the 'Exchange Transfusion Limit'(up to 1 year)
- Highest Measured Serum Bilirubin-value(up to 1 year)
- Number of Patients Having Kernicterus(up to 1 year)