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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07080398
Enrollment
90
Registered
2025-07-23
Start date
2024-11-01
Completion date
2025-07-01
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Hyperbilirubinemia

Keywords

newborn, hyperbilirubinemia, phototherapy, bilirubin, transcutaneous bilirubin, serum bilirubin

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.

Interventions

DIAGNOSTIC_TESTserum bilirubin level measurement

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

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Hours to 2 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation coefficient of transcutaneous bilirubin (TcB) and total serum bilirubin (TSB)from enrollment to 24th hour after the end of the phototherapy treatmentThe accuracy of TcB as a substitute of TSB will be evaluated through correlation and Bland-Altman analysis

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026