Clinical trial NCT06105879: Transcutaneous Bilirubin Levels From Covered Skin
Official title: Can Transcutaneous Levels of Bilirubin Obtained From Covered Skin Replace Serum Bilirubin Measurement in Neonates Undergoing Phototherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperbilirubinemia, Neonatal
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neonates with indirect hyperbilirubinemia were admitted to the NICU

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).

Eligibility criteria: 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

Primary outcomes:
measure: transcutaneous bilirubin levels measured from covered skin
timeFrame: first hour before phototherapy, after 24 hours of phototherapy, and 8 hours after discontinuing phototherapy.
measure: transcutaneous bilirubin levels measured from open skin
timeFrame: first hour before phototherapy, after 24 hours of phototherapy, and 8 hours after discontinuing phototherapy.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Training and Research Hospital
Study officials:
affiliation: Ankara Training and Research Hospital
name: Dilek Kahvecioglu, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara Training and Research Hospital
name: Dilek Kahvecioglu, Assoc.Prof.
role: STUDY_CHAIR
affiliation: Ankara Training and Research Hospital
name: Dilek Kahvecioglu, Assoc.Prof.
role: STUDY_DIRECTOR
References: