跳至主要内容
临床试验/CTRI/2025/07/091726
CTRI/2025/07/091726尚未招募不适用

The Usefulness of Transcutaneous Bilirubinometry in Newborns: Implications on Clinical Practice in Indian Population.

Dr Poorvi Bisht1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2025年8月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
97
试验地点
1
主要终点
The findings of this study will have implications for clinical practice in managing neonatal jaundice. If TcB measurements are found to be accurate and reliable, they could replace serum bilirubin measurements in some settings, reducing the need for invasive procedures and improving the care of newborns with jaundice

研究概览

简要总结

Aim:To determine the correlation between transcutaneous bilirubin (TcB) levels and total serum bilirubin levels in newborns, born in a tertiary care hospital.

Objective:

  1. To determine the accuracy of TcB measurements with respect to corresponding serum bilirubin levels.
  2. To evaluate the effectiveness of TcB measurements in predicting the need for phototherapy.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 10.00 Day(s)(—)
性别
All

入选标准

  • All newborns (less than 10 days of life) irrespective of the age of gestation, parity, mode of delivery, mode of feeding who have jaundice that seem significant to the naked eye.
  • (Krammer zone 3 and beyond) Newborns with jaundice who have not received any treatment in the form of exchange blood transfusion.
  • Newborns receiving phototherapy with a photo opaque heat reflective patch over the area of the forehead, and sternum where TCB measurement will be taken from.

排除标准

  • Neonates whose age is more than 10 days of life.
  • Neonates who needed exchange transfusion.
  • When a serum value is not available.
  • Severe multiple anomalies.
  • Patients with known liver disease, conjugated hyperbilirubinemia, or metabolic disorders that affect bilirubin metabolism.
  • Those who had culture-proven sepsis.
  • Unwillingness to participate or refusal of consent.

结局指标

主要结局

The findings of this study will have implications for clinical practice in managing neonatal jaundice. If TcB measurements are found to be accurate and reliable, they could replace serum bilirubin measurements in some settings, reducing the need for invasive procedures and improving the care of newborns with jaundice

时间窗: at baseline, 18 months

次要结局

未报告次要终点

研究者

发起方
Dr Poorvi Bisht
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

POORVI BISHT

H. N. Reliance Foundation Hospital and Research Centre

研究点 (1)

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