Accuracy of TcB Measurements During and After Phototherapy

NCT ID: NCT07080398

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-07-01

Brief Summary

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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

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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

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Neonatal Hyperbilirubinemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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term newborns

term newborns with hyperbilirubinemia requiring phototherapy

serum bilirubin level measurement

Intervention Type DIAGNOSTIC_TEST

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

late-preterm newborns

late-preterm newborns with hyperbilirubinemia requiring phototherapy

serum bilirubin level measurement

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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serum bilirubin level measurement

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

1 Hour

Maximum Eligible Age

2 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seda Yilmaz Semerci

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Health Sciences Istanbul KSS Training and Research Hospital

Istanbul, Kucukcekmece, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2021/249

Identifier Type: -

Identifier Source: org_study_id

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