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
| Tracking Information | |||||
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| First Received Date ICMJE | July 23, 2010 | ||||
| Last Updated Date | February 12, 2012 | ||||
| Start Date ICMJE | July 2010 | ||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01169740 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Transcutaneous Measurement of Jaundice in the Newborn | ||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Newborn infants admitted to normal newborn nursery |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Group/Cohort (s) | 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 |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 1500 | ||||
| Estimated Completion Date | October 2013 | ||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 28 Days | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01169740 | ||||
| Other Study ID Numbers ICMJE | Bilirubin 2010/413 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Norwegian University of Science and Technology | ||||
| Study Sponsor ICMJE | Norwegian University of Science and Technology | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Norwegian University of Science and Technology | ||||
| Verification Date | February 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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