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Transcutaneous Measurement of Jaundice in the Newborn (TcBili)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01169740
First Posted: July 26, 2010
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norwegian University of Science and Technology
July 23, 2010
July 26, 2010
March 28, 2017
July 2010
April 2013   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01169740 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Transcutaneous Measurement of Jaundice in the Newborn
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Newborn infants admitted to normal newborn nursery
  • Hyperbilirubinemia, Neonatal
  • Jaundice, Neonatal
Procedure: Measurement of bilirubin in blood and skin color
Blood sampling and analysis, measurement of skin color by transcutaneous bilirubinometry
Other Name: Diagnosis of jaundice
Neonatal jaundice
Infants born between July 1st 2010 and July 31st 2010 and admitted to normal newborn nursery
Intervention: Procedure: Measurement of bilirubin in blood and skin color
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
October 2013
April 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Newborn infant admitted to normal newborn nursery

Exclusion Criteria:

  • Informed consent not obtained
Sexes Eligible for Study: All
up to 28 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01169740
Bilirubin 2010/413
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
Not Provided
Study Chair: Vibeke Videm, MD, PhD Norwegian University of Science and Technology, Instititue director
Norwegian University of Science and Technology
March 2017
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