Transcutaneous Bilirubin Levels From Covered Skin

NCT06105879 | Completed

• 1 other identifier: 1
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperbilirubinemia, Neonatal

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (3)

Serum

Total Serum bilirubin

Device: covered or open skin

covered skin

Covered Skin Transcutaneous Bilirubin

Device: covered or open skin

exposed skin

Exposed skin Transcutaneous Bilirubin

Device: covered or open skin

Interventions

covered or open skin DEVICE

transcutaneous mesarument of covered or open skin area

Serum; covered skin; exposed skin

Eligibility Criteria

• Age: 1 Hour - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Neonates with indirect hyperbilirubinemia were admitted to the NICU

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara Training and Research Hospital: lead

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Biospecimen

Retention: NONE RETAINED

serum

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dilek Kahvecioglu, Assoc.Prof.

  Ankara Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Dilek Kahvecioglu, Assoc.Prof.

  Ankara Training and Research Hospital

  STUDY CHAIR

• Dilek Kahvecioglu, Assoc.Prof.

  Ankara Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 30, 2023
• Study Start: January 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Locations

TU (1)