Transcutaneous Bilirubin Levels From Covered Skin

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Hyperbilirubinemia, Neonatal

Intervention / Treatment
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* Device: covered or open skin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Serum<br>Total Serum bilirubin | Device: covered or open skin<br>* transcutaneous mesarument of covered or open skin area<br>|
| covered skin<br>Covered Skin Transcutaneous Bilirubin | Device: covered or open skin<br>* transcutaneous mesarument of covered or open skin area<br>|
| exposed skin<br>Exposed skin Transcutaneous Bilirubin | Device: covered or open skin<br>* transcutaneous mesarument of covered or open skin area<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transcutaneous bilirubin levels measured from covered skin | 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 | 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. |