Transcutaneous Measurement of Jaundice in the Newborn (TcBili)

March 27, 2017 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, N-7006
        • St. Olavs University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newborn infants admitted to normal newborn nursery

Description

Inclusion Criteria:

  • Newborn infant admitted to normal newborn nursery

Exclusion Criteria:

  • Informed consent not obtained

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neonatal jaundice
Infants born between July 1st 2010 and July 31st 2010 and admitted to normal newborn nursery
Procedure: Measurement of bilirubin in blood and skin color
Blood sampling and analysis, measurement of skin color by transcutaneous bilirubinometry
Other Names:
  • Diagnosis of jaundice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Investigators

  • Study Chair: Vibeke Videm, MD, PhD, Norwegian University of Science and Technology, Instititue director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 23, 2010

First Submitted That Met QC Criteria

July 23, 2010

First Posted (Estimate)

July 26, 2010

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bilirubin 2010/413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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