Clinical Trial: Transcutaneous Measurement of Jaundice in the Newborn

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary: 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.
Sponsor: Norwegian University of Science and Technology

Current 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


Original Primary Outcome: Same as current

Current Secondary Outcome: Differences in TcB measured at the forehead or at the sternum [ Time Frame: 12 months ]

To have statistical strength for comparison of the two tests between 1500 and 2000 patients are needed


Original Secondary Outcome: Same as current

Information By: Norwegian University of Science and Technology

Dates:
Date Received: July 23, 2010
Date Started: July 2010
Date Completion:
Last Updated: March 27, 2017
Last Verified: March 2017