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临床试验/NCT07080398
NCT07080398已完成不适用

The Utility of Transcutaneous Bilirubin Measurement in Term and Late-Preterm Infants With Hyperbilirubinemia: A Prospective Observational Study During and After Phototherapy

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Correlation coefficient of transcutaneous bilirubin (TcB) and total serum bilirubin (TSB)

研究概览

简要总结

This study aimed to assess the accuracy of transcutaneous bilirubin measurements in term and late-preterm infants undergoing phototherapy. Transcutaneous bilirubin levels were measured from different anatomical sites during and after treatment, and compared to total serum bilirubin levels. The agreement between the two methods was evaluated using Bland-Altman plots.

详细描述

This study focused on evaluating the accuracy of transcutaneous bilirubin measurements in term and late-preterm infants who were receiving phototherapy treatment. Transcutaneous bilirubin levels were measured at two different locations - the glabella (forehead) and lower abdomen - while the infants were undergoing phototherapy. These measurements were then compared to total serum bilirubin levels, which is the gold standard for assessing bilirubin levels in the blood.

The researchers used Bland-Altman plots to analyze the agreement between the transcutaneous bilirubin measurements and total serum bilirubin levels.

By comparing the transcutaneous bilirubin measurements to total serum bilirubin levels using Bland-Altman plots, the researchers were able to determine the accuracy of the transcutaneous measurements in this specific population of infants undergoing phototherapy. This information is important for healthcare providers to ensure that they are using the most accurate and reliable method for monitoring bilirubin levels in infants receiving treatment for jaundice.

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
1 Hour 至 2 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Newborn infants less than 7 days of life
  • Hyperbilirubinemia requiring phototherapy
  • Indirect hyperbilirubinemia
  • Newborn infants who are born between 35-42 weeks of gestation

排除标准

  • Direct hyperbilirubinemia
  • Disease states other than hyperbilirubinemia
  • Congenital abnormalities
  • Chromosomal abnormalities
  • Poor peripheral perfusion

结局指标

主要结局

Correlation coefficient of transcutaneous bilirubin (TcB) and total serum bilirubin (TSB)

时间窗: from enrollment to 24th hour after the end of the phototherapy treatment

The accuracy of TcB as a substitute of TSB will be evaluated through correlation and Bland-Altman analysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seda Yilmaz Semerci

Assoc. Prof.

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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