Transcutaneous Measurement of Jaundice in the Newborn (TcBili)
This study is ongoing, but not recruiting participants.
Sponsor:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01169740
First received: July 23, 2010
Last updated: February 12, 2012
Last verified: February 2012
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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
| Estimated Enrollment: | 1500 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated 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
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: | February 12, 2012 |
| 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 Jaundice Jaundice, Neonatal Hyperbilirubinemia, Neonatal Pathologic Processes Skin Manifestations Signs and Symptoms |
Infant, Newborn, Diseases Bilirubin Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013