Hyperbilirubinemia, NeonatalNCT06105879
Transcutaneous Bilirubin Levels From Covered Skin
An observational study of Hyperbilirubinemia, Neonatal, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 28 days
- Conditions the study is for
- Hyperbilirubinemia, Neonatal
- What is being tested?
- covered or open skin
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jun 2023
- 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 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates with indirect hyperbilirubinemia were admitted to the NICU
Who may be able to join
- Aged 0-28 days, Diagnosis of indirect hyperbilirubinemia Parent/guardian consent was obtained.
Who cannot join
- Direct hyperbilirubinemia, Major congenital anomaly, Severe sepsis, Circulatory disorder, Need for blood exchange, Rehospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Transcutaneous Levels of Bilirubin Obtained From Covered Skin Replace Serum Bilirubin Measurement in Neonates Undergoing Phototherapy
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.
Read the 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).
- Conditions
- Hyperbilirubinemia, Neonatal
- Being tested
- covered or open skin
- Medical subject headings
- Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
covered or open skinDevice
transcutaneous mesarument of covered or open skin area
| Study group | Role | What they receive |
|---|---|---|
| Serum | Total Serum bilirubin Receives: Device: covered or open skin | |
| covered skin | Covered Skin Transcutaneous Bilirubin Receives: Device: covered or open skin | |
| exposed skin | Exposed skin Transcutaneous Bilirubin Receives: Device: covered or open skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
transcutaneous bilirubin levels measured from covered skin
correlation between transcutaneous bilirubin levels measured from covered skin and total serum bilirubin measurements in newborns
Measured: 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
Measured: first hour before phototherapy, after 24 hours of phototherapy, and 8 hours after discontinuing phototherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Jan 2022
- Primary completion1 Jun 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbilirubinemia, NeonatalStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Kahvecioğlu, Ankara Training and Research Hospital
- Investigators
- Dilek Kahvecioglu, Assoc.Prof., Principal investigator, Ankara Training and Research HospitalDilek Kahvecioglu, Assoc.Prof., Study chair, Ankara Training and Research HospitalDilek Kahvecioglu, Assoc.Prof., Study director, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105879
- Sponsor's protocol ID
- 1
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Transcutaneous Levels of Bilirubin Obtained From Covered Skin Replace Serum Bilirubin Measurement in Neonates Undergoing Phototherapy
- ClinicalTrials.gov ID
- NCT06105879
- Acronym / sponsor ID
- 1
- Conditions
- Hyperbilirubinemia, Neonatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 30 Oct 2023 (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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Serum | – | Device: covered or open skinTotal Serum bilirubin |
| covered skin | – | Device: covered or open skinCovered Skin Transcutaneous Bilirubin |
| exposed skin | – | Device: covered or open skinExposed skin Transcutaneous Bilirubin |
Who may qualify
- Ages
- 1 hour to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates with indirect hyperbilirubinemia were admitted to the NICU
Key inclusion criteria (1 listed)
- Aged 0-28 days, Diagnosis of indirect hyperbilirubinemia Parent/guardian consent was obtained.
Key exclusion criteria (1 listed)
- Direct hyperbilirubinemia, Major congenital anomaly, Severe sepsis, Circulatory disorder, Need for blood exchange, Rehospitalization
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 |
|---|---|---|
| covered or open skintranscutaneous mesarument of covered or open skin area | Device | Serum, covered skin, exposed skin |
Primary outcome
transcutaneous bilirubin levels measured from covered skin
Time frame: 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
Time frame: 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
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 30 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Hyperbilirubinemia, Neonatal
Recruiting
Abdominal Massage for Newborn Jaundice
Neonatal Jaundice
Recruiting
Foot Reflexology and Massage in Neonates Receiving Phototherapy
Neonatal Hyperbilirubinemia
Active, not recruiting
Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
Prematurity, Low Birth Weight
Active, not recruiting
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Newborn Jaundice
Not yet recruiting
Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
Indirect Hyperbilirubinemia
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.
Dilek Kahvecioglu, Assoc.Prof. principal investigator
Ankara Training and Research Hospital
Dilek Kahvecioglu, Assoc.Prof. study chair
Ankara Training and Research Hospital
Dilek Kahvecioglu, Assoc.Prof. study director
Ankara Training and Research Hospital
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 Hyperbilirubinemia, Neonatal, run by Ankara 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 1 inclusion and 1 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 30 Oct 2023. 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?
transcutaneous bilirubin levels measured from covered skin (time frame: first hour before phototherapy, after 24 hours of phototherapy, and 8 hours after discontinuing phototherapy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2023.