Can Transcutaneous Levels of Bilirubin Obtained From Covered Skin Replace Serum Bilirubin Measurement in Neonates Undergoing Phototherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- transcutaneous bilirubin levels measured from covered skin
研究概览
简要总结
The aim of this study was to evaluate the levels of total serum bilirubin and transcutaneous bilirubin in newborns, measured in both covered and exposed areas, before phototherapy, 24th hour of phototherapy and 8 hours after cessation of phototherapy. The study included term and preterm newborns that required phototherapy between postnatal days 0-28. Total serum bilirubin levels and transcutaneous bilirubin measurements were obtained using the MBJ20-2019 Transcutaneous Handheld Bilirubinometer (Beijing M&B Electronic Instruments Co. Ltd. China, 2019) from both exposed (sternal) and unexposed (forehead, covered with a radio-opaque patch) areas before, at 24th hours and eight hours after phototherapy.
详细描述
Aim: This study aimed to evaluate total serum bilirubin and transcutaneous bilirubin levels measured from covered and exposed areas in newborns before phototherapy, after 24 hours of phototherapy, and 8 hours after discontinuing phototherapy.
Materials and Methods
Term and preterm newborns who needed phototherapy between postnatal days 0-28 were included in the study. Total serum bilirubin values and transcutaneous bilirubin measurements by MBJ20-2019 Transcutaneous Handheld Bilirubinometer (Beijing M&B Electronic Instruments Co. Ltd. China, 2019) from the exposed area (on sternum) and an unexposed area (forehead, covered with a radioopaque patch) were obtained before starting phototherapy, after 24 hours of phototherapy, and at 8 hours after phototherapy. The results were analyzed statistically using intraclass correlation coefficients (ICC).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Hour 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 0-28 days, Diagnosis of indirect hyperbilirubinemia Parent/guardian consent was obtained.
排除标准
- •Direct hyperbilirubinemia, Major congenital anomaly, Severe sepsis, Circulatory disorder, Need for blood exchange, Rehospitalization
结局指标
主要结局
transcutaneous bilirubin levels measured from covered skin
时间窗: first hour before phototherapy, after 24 hours of phototherapy, and 8 hours after discontinuing phototherapy.
correlation between transcutaneous bilirubin levels measured from covered skin and total serum bilirubin measurements in newborns
transcutaneous bilirubin levels measured from open skin
时间窗: first hour before phototherapy, after 24 hours of phototherapy, and 8 hours after discontinuing phototherapy.
correlation between transcutaneous bilirubin levels measured from open skin and total serum bilirubin measurements in newborns
次要结局
未报告次要终点
研究者
Dilek Kahvecioğlu
Assoc. Prof.
Ankara Training and Research Hospital