Transcutaneous Bilirubin Levels From Covered Skin

Hyperbilirubinemia, Neonatal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06105879
• Other study ID #: 1
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: October 2023
• Source: Ankara Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal

Intervention

Device:
• covered or open skin
transcutaneous mesarument of covered or open skin area

Locations

Country	Name	City	State
Turkey	Ankara Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.