Transcutaneous Measurement of Jaundice in the Newborn (TcBili)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01169740
First received: July 23, 2010
Last updated: October 27, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Hyperbilirubinemia, Neonatal
Jaundice, Neonatal
Procedure: Measurement of bilirubin in blood and skin color

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Transcutaneous or Laboratory Measurement of Bilirubin in the Newborn

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Comparison of transcutaneous bilirubin (skin color, TcB) and bilirubin measured in a blood sample (TsB) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To have statistical strength for comparison of the two tests between 1500 and 2000 patients are needed


Secondary Outcome Measures:
  • Differences in TcB measured at the forehead or at the sternum [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To have statistical strength for comparison of the two tests between 1500 and 2000 patients are needed


Enrollment: 1000
Study Start Date: July 2010
Study Completion Date: October 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Diagnosis of jaundice

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.

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Newborn infants admitted to normal newborn nursery

Criteria

Inclusion Criteria:

  • Newborn infant admitted to normal newborn nursery

Exclusion Criteria:

  • Informed consent not obtained
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01169740

Locations
Norway
St. Olavs University Hospital
Trondheim, Norway, N-7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Study Chair: Vibeke Videm, MD, PhD Norwegian University of Science and Technology, Instititue director
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01169740     History of Changes
Other Study ID Numbers: Bilirubin 2010/413
Study First Received: July 23, 2010
Last Updated: October 27, 2014
Health Authority: Norway: Ethics Committee

Keywords provided by Norwegian University of Science and Technology:
Hyperbilirubinemia
Neonatal
Serum bilirubin
Transcutaneous bilirubin
Skin color

Additional relevant MeSH terms:
Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Jaundice
Jaundice, Neonatal
Infant, Newborn, Diseases
Pathologic Processes
Signs and Symptoms
Skin Manifestations
Bilirubin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 29, 2014