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NCT01169740 Clinical Trial

Transcutaneous Measurement of Jaundice in the Newborn

Jaundice, Neonatal Clinical Trial

— TcBili  

Official title:
Comparison of Transcutaneous or Laboratory Measurement of Bilirubin in the Newborn

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01169740
Other study ID # Bilirubin 2010/413
Secondary ID
Status Completed
Phase N/A
First received July 23, 2010
Last updated March 27, 2017
Start date July 2010
Est. completion date October 2013

Study information
Verified date March 2017
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date October 2013
Est. primary completion date April 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 28 Days
Eligibility Inclusion Criteria:

- Newborn infant admitted to normal newborn nursery

Exclusion Criteria:

- Informed consent not obtained

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Measurement of bilirubin in blood and skin color
Blood sampling and analysis, measurement of skin color by transcutaneous bilirubinometry

Locations
Country Name City State
Norway St. Olavs University Hospital Trondheim

Sponsors (1)
Lead Sponsor Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 12 months
Secondary 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 12 months
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