Neonatal HyperbilirubinemiaNCT07080398
Accuracy of TcB Measurements During and After Phototherapy
An observational study of Neonatal Hyperbilirubinemia, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to assess the accuracy of transcutaneous bilirubin measurements in term and late-preterm infants undergoing phototherapy. Transcutaneous bilirubin levels were measured from different anatomical sites during and after treatment, and compared to total serum bilirubin levels. Read more about this study
- Who is it for?
- Ages 1 hour to 2 weeks
- Conditions the study is for
- Neonatal Hyperbilirubinemia
- What is being tested?
- serum bilirubin level measurement
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Jul 2025
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 2 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Term and late-preterm newborn infants with hyperbilirubinemia requiring photothrepy will be included.
Who may be able to join
- Newborn infants less than 7 days of life
- Hyperbilirubinemia requiring phototherapy
- Indirect hyperbilirubinemia
- Newborn infants who are born between 35-42 weeks of gestation
Who cannot join
- Direct hyperbilirubinemia
- Disease states other than hyperbilirubinemia
- Congenital abnormalities
- Chromosomal abnormalities
- Poor peripheral perfusion
- Edema
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Istanbul KSS Training and Research Hospital
Istanbul, Kucukcekmece, 34303
About this study
Official title: The Utility of Transcutaneous Bilirubin Measurement in Term and Late-Preterm Infants With Hyperbilirubinemia: A Prospective Observational Study During and After Phototherapy
This study aimed to assess the accuracy of transcutaneous bilirubin measurements in term and late-preterm infants undergoing phototherapy. Transcutaneous bilirubin levels were measured from different anatomical sites during and after treatment, and compared to total serum bilirubin levels. The agreement between the two methods was evaluated using Bland-Altman plots.
Read the detailed description
This study focused on evaluating the accuracy of transcutaneous bilirubin measurements in term and late-preterm infants who were receiving phototherapy treatment. Transcutaneous bilirubin levels were measured at two different locations - the glabella (forehead) and lower abdomen - while the infants were undergoing phototherapy. These measurements were then compared to total serum bilirubin levels, which is the gold standard for assessing bilirubin levels in the blood.
The researchers used Bland-Altman plots to analyze the agreement between the transcutaneous bilirubin measurements and total serum bilirubin levels.
By comparing the transcutaneous bilirubin measurements to total serum bilirubin levels using Bland-Altman plots, the researchers were able to determine the accuracy of the transcutaneous measurements in this specific population of infants undergoing phototherapy. This information is important for healthcare providers to ensure that they are using the most accurate and reliable method for monitoring bilirubin levels in infants receiving treatment for jaundice.
- Conditions
- Neonatal Hyperbilirubinemia
- Being tested
- serum bilirubin level measurement
- Keywords
- newborn, hyperbilirubinemia, phototherapy, bilirubin, transcutaneous bilirubin, serum bilirubin
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum bilirubin level measurementDiagnostic test
Total serum bilirubin levels and concurrent transcutaneous bilirubin measurements will be done and the results will be evaluated comperatively.
| Study group | Role | What they receive |
|---|---|---|
| term newborns | term newborns with hyperbilirubinemia requiring phototherapy Receives: Diagnostic Test: serum bilirubin level measurement | |
| late-preterm newborns | late-preterm newborns with hyperbilirubinemia requiring phototherapy Receives: Diagnostic Test: serum bilirubin level measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient of transcutaneous bilirubin (TcB) and total serum bilirubin (TSB)
The accuracy of TcB as a substitute of TSB will be evaluated through correlation and Bland-Altman analysis
Measured: from enrollment to 24th hour after the end of the phototherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Nov 2024
- Primary completion1 May 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal HyperbilirubinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Yilmaz Semerci, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080398
- Sponsor's protocol ID
- 2021/249
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: can be shared after the study is published.
Publications
Besnili Acar D, Yilmaz Semerci S. The Utility of Transcutaneous Bilirubin Measurement in Newborns with Hyperbilirubinemia: A Prospective, Observational Study during and after Phototherapy. Am J Perinatol. 2026 Apr 10. doi: 10.1055/a-2841-9781. Online ahead of print.
PubMed 41887606
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Transcutaneous Bilirubin Measurement in Term and Late-Preterm Infants With Hyperbilirubinemia: A Prospective Observational Study During and After Phototherapy
- ClinicalTrials.gov ID
- NCT07080398
- Acronym / sponsor ID
- 2021/249
- Conditions
- Neonatal Hyperbilirubinemia
- Keywords
- newborn, hyperbilirubinemia, phototherapy, bilirubin, transcutaneous bilirubin, serum bilirubin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to assess the accuracy of transcutaneous bilirubin measurements in term and late-preterm infants undergoing phototherapy. Transcutaneous bilirubin levels were measured from different anatomical sites during and after treatment, and compared to total serum bilirubin levels. The agreement between the two methods was evaluated using Bland-Altman plots.
Detailed description
This study focused on evaluating the accuracy of transcutaneous bilirubin measurements in term and late-preterm infants who were receiving phototherapy treatment. Transcutaneous bilirubin levels were measured at two different locations - the glabella (forehead) and lower abdomen - while the infants were undergoing phototherapy. These measurements were then compared to total serum bilirubin levels, which is the gold standard for assessing bilirubin levels in the blood.
The researchers used Bland-Altman plots to analyze the agreement between the transcutaneous bilirubin measurements and total serum bilirubin levels.
By comparing the transcutaneous bilirubin measurements to total serum bilirubin levels using Bland-Altman plots, the researchers were able to determine the accuracy of the transcutaneous measurements in this specific population of infants undergoing phototherapy. This information is important for healthcare providers to ensure that they are using the most accurate and reliable method for monitoring bilirubin levels in infants receiving treatment for jaundice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| term newborns | – | Diagnostic Test: serum bilirubin level measurementterm newborns with hyperbilirubinemia requiring phototherapy |
| late-preterm newborns | – | Diagnostic Test: serum bilirubin level measurementlate-preterm newborns with hyperbilirubinemia requiring phototherapy |
Who may qualify
- Ages
- 1 hour to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Term and late-preterm newborn infants with hyperbilirubinemia requiring photothrepy will be included.
Key inclusion criteria (4 listed)
- Newborn infants less than 7 days of life
- Hyperbilirubinemia requiring phototherapy
- Indirect hyperbilirubinemia
- Newborn infants who are born between 35-42 weeks of gestation
Key exclusion criteria (6 listed)
- Direct hyperbilirubinemia
- Disease states other than hyperbilirubinemia
- Congenital abnormalities
- Chromosomal abnormalities
- Poor peripheral perfusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum bilirubin level measurementTotal serum bilirubin levels and concurrent transcutaneous bilirubin measurements will be done and the results will be evaluated comperatively. | Diagnostic test | late-preterm newborns, term newborns |
Primary outcome
Correlation coefficient of transcutaneous bilirubin (TcB) and total serum bilirubin (TSB)
Time frame: from enrollment to 24th hour after the end of the phototherapy treatment
The accuracy of TcB as a substitute of TSB will be evaluated through correlation and Bland-Altman analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Derived from this study: PubMed 41887606Besnili Acar D, Yilmaz Semerci S. The Utility of Transcutaneous Bilirubin Measurement in Newborns with Hyperbilirubinemia: A Prospective, Observational Study during and after Phototherapy. Am J Perinatol. 2026 Apr 10. doi: 10.1055/a-2841-9781. Online ahead of print.
- Individual participant dataSharing planned: Undecided. can be shared after the study is published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Hyperbilirubinemia, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient of transcutaneous bilirubin (TcB) and total serum bilirubin (TSB) (time frame: from enrollment to 24th hour after the end of the phototherapy treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07080398, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.