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Completed

NCT Number: NCT07080398

Accuracy of TcB Measurements During and After Phototherapy

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.

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Key information

Conditions

Neonatal Hyperbilirubinemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 hour–2 week

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Health Sciences Istanbul KSS Training and Research Hospital

Istanbul, Kucukcekmece, 34303, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

serum bilirubin level measurement

Diagnostic Test

Total serum bilirubin levels and concurrent transcutaneous bilirubin measurements will be done and the results will be evaluated comperatively.

Primary outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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