Transcutaneous Bilirubin Levels From Covered Skin

October 26, 2023 updated by: Dilek Kahvecioğlu, Ankara Training and Research Hospital

Can Transcutaneous Levels of Bilirubin Obtained From Covered Skin Replace Serum Bilirubin Measurement in Neonates Undergoing Phototherapy

The aim of this study was to evaluate the levels of total serum bilirubin and transcutaneous bilirubin in newborns, measured in both covered and exposed areas, before phototherapy, 24th hour of phototherapy and 8 hours after cessation of phototherapy. The study included term and preterm newborns that required phototherapy between postnatal days 0-28. Total serum bilirubin levels and transcutaneous bilirubin measurements were obtained using the MBJ20-2019 Transcutaneous Handheld Bilirubinometer (Beijing M&B Electronic Instruments Co. Ltd. China, 2019) from both exposed (sternal) and unexposed (forehead, covered with a radio-opaque patch) areas before, at 24th hours and eight hours after phototherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim: This study aimed to evaluate total serum bilirubin and transcutaneous bilirubin levels measured from covered and exposed areas in newborns before phototherapy, after 24 hours of phototherapy, and 8 hours after discontinuing phototherapy.

Materials and Methods: Term and preterm newborns who needed phototherapy between postnatal days 0-28 were included in the study. Total serum bilirubin values and transcutaneous bilirubin measurements by MBJ20-2019 Transcutaneous Handheld Bilirubinometer (Beijing M&B Electronic Instruments Co. Ltd. China, 2019) from the exposed area (on sternum) and an unexposed area (forehead, covered with a radioopaque patch) were obtained before starting phototherapy, after 24 hours of phototherapy, and at 8 hours after phototherapy. The results were analyzed statistically using intraclass correlation coefficients (ICC).

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Neonates with indirect hyperbilirubinemia were admitted to the NICU

Description

Inclusion Criteria:

Aged 0-28 days, Diagnosis of indirect hyperbilirubinemia Parent/guardian consent was obtained.

Exclusion Criteria:

Direct hyperbilirubinemia, Major congenital anomaly, Severe sepsis, Circulatory disorder, Need for blood exchange, Rehospitalization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Serum
Total Serum bilirubin
Device: covered or open skin
transcutaneous mesarument of covered or open skin area
covered skin
Covered Skin Transcutaneous Bilirubin
Device: covered or open skin
transcutaneous mesarument of covered or open skin area
exposed skin
Exposed skin Transcutaneous Bilirubin
Device: covered or open skin
transcutaneous mesarument of covered or open skin area

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
transcutaneous bilirubin levels measured from covered skin
Time Frame: first hour before phototherapy, after 24 hours of phototherapy, and 8 hours after discontinuing phototherapy.
correlation between transcutaneous bilirubin levels measured from covered skin and total serum bilirubin measurements in newborns
first hour before phototherapy, after 24 hours of phototherapy, and 8 hours after discontinuing phototherapy.
transcutaneous bilirubin levels measured from open skin
Time Frame: first hour before phototherapy, after 24 hours of phototherapy, and 8 hours after discontinuing phototherapy.
correlation between transcutaneous bilirubin levels measured from open skin and total serum bilirubin measurements in newborns
first hour before phototherapy, after 24 hours of phototherapy, and 8 hours after discontinuing phototherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Training and Research Hospital

Investigators

  • Principal Investigator: Dilek Kahvecioglu, Assoc.Prof., Ankara Training and Research Hospital
  • Study Chair: Dilek Kahvecioglu, Assoc.Prof., Ankara Training and Research Hospital
  • Study Director: Dilek Kahvecioglu, Assoc.Prof., Ankara Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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