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Transcutaneous Measurement of Jaundice in the Newborn

Comparison of Transcutaneous or Laboratory Measurement of Bilirubin in the Newborn

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01169740
Acronym
TcBili
Enrollment
1000
Registered
2010-07-26
Start date
2010-07-31
Completion date
2013-10-31
Last updated
2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperbilirubinemia, Neonatal, Jaundice, Neonatal

Keywords

Hyperbilirubinemia, Neonatal, Serum bilirubin, Transcutaneous bilirubin, Skin color

Brief 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.

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.

Interventions

PROCEDUREMeasurement of bilirubin in blood and skin color

Blood sampling and analysis, measurement of skin color by transcutaneous bilirubinometry

Sponsors

Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
Yes

Inclusion criteria

* Newborn infant admitted to normal newborn nursery

Exclusion criteria

* Informed consent not obtained

Design outcomes

Primary

MeasureTime frameDescription
Comparison of transcutaneous bilirubin (skin color, TcB) and bilirubin measured in a blood sample (TsB)12 monthsTo have statistical strength for comparison of the two tests between 1500 and 2000 patients are needed

Secondary

MeasureTime frameDescription
Differences in TcB measured at the forehead or at the sternum12 monthsTo have statistical strength for comparison of the two tests between 1500 and 2000 patients are needed

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026