Transcutaneous Bilirubin Levels From Covered Skin

NCT ID: NCT06105879

Last Updated: 2023-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperbilirubinemia, Neonatal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Serum

Total Serum bilirubin

covered or open skin

Intervention Type DEVICE

transcutaneous mesarument of covered or open skin area

covered skin

Covered Skin Transcutaneous Bilirubin

covered or open skin

Intervention Type DEVICE

transcutaneous mesarument of covered or open skin area

exposed skin

Exposed skin Transcutaneous Bilirubin

covered or open skin

Intervention Type DEVICE

transcutaneous mesarument of covered or open skin area

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

covered or open skin

transcutaneous mesarument of covered or open skin area

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Hour

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dilek Kahvecioğlu

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dilek Kahvecioglu, Assoc.Prof.

Role: PRINCIPAL_INVESTIGATOR

Ankara Training and Research Hospital

Dilek Kahvecioglu, Assoc.Prof.

Role: STUDY_CHAIR

Ankara Training and Research Hospital

Dilek Kahvecioglu, Assoc.Prof.

Role: STUDY_DIRECTOR

Ankara Training and Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ankara Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Value of Transcutaneous Bilirubin Devices
NCT06232174 NOT_YET_RECRUITING
Cycled Phototherapy
NCT03927833 ACTIVE_NOT_RECRUITING NA
Hyperbilirubinemia in Full-term Neonates
NCT06238349 RECRUITING PHASE4