Transcutaneous Bilirubin Levels From Covered Skin

Completed

• Conditions: Hyperbilirubinemia, Neonatal
• Interventions: Device: covered or open skin

• Registration Number: NCT06105879
• Lead Sponsor: Ankara Training and Research Hospital

Brief 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.

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 Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-06-01
• Study Completion: 2023-06-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-26
• Last Update Submitted: 2023-10-26
• Study First Posted: 2023-10-30
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
covered skin	covered or open skin	Covered Skin Transcutaneous Bilirubin
Serum	covered or open skin	Total Serum bilirubin
exposed skin	covered or open skin	Exposed skin Transcutaneous Bilirubin

Primary Outcome Measures

Name	Time	Method
transcutaneous bilirubin levels measured from covered skin	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
transcutaneous bilirubin levels measured from open skin	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

Trial Locations

Locations (1)

Ankara Training and Research Hospital; 🇹🇷 Ankara, Turkey