Hyperbilirubinemia, NeonatalTcBiliNCT01169740
Transcutaneous Measurement of Jaundice in the Newborn
An observational study of Hyperbilirubinemia, Neonatal and Jaundice, Neonatal, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Prospective comparison of measurement of bilirubin in jaundiced newborns by a transcutaneous device (bilirubinometer) and laboratory analysis of blood samples. We hypothesise that correlation of the two measurements depend on bilirubin level, gestational age as well as postnatal age. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
- What is being tested?
- Measurement of bilirubin in blood and skin color
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2010to Oct 2013
- 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 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Newborn infants admitted to normal newborn nursery
Who may be able to join
- Newborn infant admitted to normal newborn nursery
Who cannot join
- Informed consent not obtained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Transcutaneous or Laboratory Measurement of Bilirubin in the Newborn
Prospective comparison of measurement of bilirubin in jaundiced newborns by a transcutaneous device (bilirubinometer) and laboratory analysis of blood samples.
We hypothesise that correlation of the two measurements depend on bilirubin level, gestational age as well as postnatal age.
Read the detailed description
Whenever a blood sample is drawn for measurement of bilirubin in a newborn, a transcutaneous measurement of skin yellow color will be made. Such measurements will also be included in all infants when a CRP-test (blood sample for C-reactive protein) has been ordered, as well as in connection with the routine blood sampling for metabolic screening. Only infants where parents have given written consent for their infant will be included in the study.
- Conditions
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
- Being tested
- Measurement of bilirubin in blood and skin color
- Keywords
- Hyperbilirubinemia, Neonatal, Serum bilirubin, Transcutaneous bilirubin, Skin color
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of bilirubin in blood and skin colorProcedure or surgery
Also called Diagnosis of jaundice
Blood sampling and analysis, measurement of skin color by transcutaneous bilirubinometry
| Study group | Role | What they receive |
|---|---|---|
| Neonatal jaundice | Infants born between July 1st 2010 and July 31st 2010 and admitted to normal newborn nursery Receives: Procedure: Measurement of bilirubin in blood and skin color |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of transcutaneous bilirubin (skin color, TcB) and bilirubin measured in a blood sample (TsB)
To have statistical strength for comparison of the two tests between 1500 and 2000 patients are needed
Measured: 12 months
Secondary outcomes (1)
Differences in TcB measured at the forehead or at the sternum
To have statistical strength for comparison of the two tests between 1500 and 2000 patients are needed
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2013
- Study completionOct 2013
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.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vibeke Videm, MD, PhD, Study chair, Norwegian University of Science and Technology, Instititue director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169740
- Sponsor's protocol ID
- Bilirubin 2010/413
- Acronym
- TcBili
- Status last verified
- Mar 2017
- First submitted
- 23 Jul 2010
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Transcutaneous or Laboratory Measurement of Bilirubin in the Newborn
- ClinicalTrials.gov ID
- NCT01169740
- Acronym / sponsor ID
- TcBili / Bilirubin 2010/413
- Conditions
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
- Keywords
- Hyperbilirubinemia, Neonatal, Serum bilirubin, Transcutaneous bilirubin, Skin color
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Jul 2010 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 26 Jul 2010 (estimated)
- 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.
Prospective comparison of measurement of bilirubin in jaundiced newborns by a transcutaneous device (bilirubinometer) and laboratory analysis of blood samples.
We hypothesise that correlation of the two measurements depend on bilirubin level, gestational age as well as postnatal age.
Detailed description
Whenever a blood sample is drawn for measurement of bilirubin in a newborn, a transcutaneous measurement of skin yellow color will be made. Such measurements will also be included in all infants when a CRP-test (blood sample for C-reactive protein) has been ordered, as well as in connection with the routine blood sampling for metabolic screening. Only infants where parents have given written consent for their infant will be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonatal jaundice | – | Procedure: Measurement of bilirubin in blood and skin colorInfants born between July 1st 2010 and July 31st 2010 and admitted to normal newborn nursery |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Newborn infants admitted to normal newborn nursery
Key inclusion criteria (1 listed)
- Newborn infant admitted to normal newborn nursery
Key exclusion criteria (1 listed)
- Informed consent not obtained
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 |
|---|---|---|
| Measurement of bilirubin in blood and skin colorAlso: Diagnosis of jaundiceBlood sampling and analysis, measurement of skin color by transcutaneous bilirubinometry | Procedure or surgery | Neonatal jaundice |
Primary outcome
Comparison of transcutaneous bilirubin (skin color, TcB) and bilirubin measured in a blood sample (TsB)
Time frame: 12 months
To have statistical strength for comparison of the two tests between 1500 and 2000 patients are needed
1 secondary outcome
Differences in TcB measured at the forehead or at the sternum
Time frame: 12 months
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 28 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Vibeke Videm, MD, PhD study chair
Norwegian University of Science and Technology, Instititue director
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 and Jaundice, Neonatal, run by Norwegian University of Science and Technology at 1 site in Norway.
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 28 Mar 2017. 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 Norway. 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?
Comparison of transcutaneous bilirubin (skin color, TcB) and bilirubin measured in a blood sample (TsB) (time frame: 12 months). 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 28 Mar 2017.