Accuracy of TcB Measurements During and After Phototherapy

NCT07080398 | Completed

• 1 other identifier: 2021/249
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Hyperbilirubinemia

Keywords

newborn; hyperbilirubinemia; phototherapy; bilirubin; transcutaneous bilirubin; serum bilirubin

Outcome Measures

Primary Outcomes (1)

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

  The accuracy of TcB as a substitute of TSB will be evaluated through correlation and Bland-Altman analysis

  from enrollment to 24th hour after the end of the phototherapy treatment

Study Arms (2)

term newborns

term newborns with hyperbilirubinemia requiring phototherapy

Diagnostic Test: serum bilirubin level measurement

late-preterm newborns

late-preterm newborns with hyperbilirubinemia requiring phototherapy

Diagnostic Test: serum bilirubin level measurement

Interventions

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.

late-preterm newborns; term newborns

Eligibility Criteria

• Age: 1 Hour - 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Term and late-preterm newborn infants with hyperbilirubinemia requiring photothrepy will be included.

You may qualify if:

• Newborn infants less than 7 days of life
• Hyperbilirubinemia requiring phototherapy
• Indirect hyperbilirubinemia
• Newborn infants who are born between 35-42 weeks of gestation

You may not qualify if:

• Direct hyperbilirubinemia
• Disease states other than hyperbilirubinemia
• Congenital abnormalities
• Chromosomal abnormalities
• Poor peripheral perfusion
• Edema

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Istanbul KSS Training and Research Hospital

Istanbul, Kucukcekmece, 34303, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum bilirubin level

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Hyperbilirubinemia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 23, 2025
• Study Start: November 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

TU (1)