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Accuracy of TcB Measurements During and After Phototherapy

Completed
Conditions
Neonatal Hyperbilirubinemia
Registration Number
NCT07080398
Lead Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
Inclusion Criteria
  • Newborn infants less than 7 days of life
  • Hyperbilirubinemia requiring phototherapy
  • Indirect hyperbilirubinemia
  • Newborn infants who are born between 35-42 weeks of gestation
Exclusion Criteria
  • Direct hyperbilirubinemia
  • Disease states other than hyperbilirubinemia
  • Congenital abnormalities
  • Chromosomal abnormalities
  • Poor peripheral perfusion
  • Edema

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Correlation coefficient of transcutaneous bilirubin (TcB) and total serum bilirubin (TSB)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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Health Sciences Istanbul KSS Training and Research Hospital

🇹🇷

Istanbul, Kucukcekmece, Turkey

University of Health Sciences Istanbul KSS Training and Research Hospital
🇹🇷Istanbul, Kucukcekmece, Turkey

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