NCT07080398

Accuracy of TcB Measurements During and After Phototherapy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 90 (actual)
• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital · Academic / Other
• Sex: All
• Age: 1 Hour – 2 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Neonatal Hyperbilirubinemia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	serum bilirubin level measurement	Total serum bilirubin levels and concurrent transcutaneous bilirubin measurements will be done and the results will be evaluated comperatively.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-05-01
• Completion: 2025-07-01
• First posted: 2025-07-23
• Last updated: 2025-07-23

Locations

1 site across 1 country: Turkey (Türkiye)