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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonatal jaundice | Infants born between July 1st 2010 and July 31st 2010 and admitted to normal newborn nursery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement of bilirubin in blood and skin color | Procedure | Blood sampling and analysis, measurement of skin color by transcutaneous bilirubinometry |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of transcutaneous bilirubin (skin color, TcB) and bilirubin measured in a blood sample (TsB) | To have statistical strength for comparison of the two tests between 1500 and 2000 patients are needed | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in TcB measured at the forehead or at the sternum | To have statistical strength for comparison of the two tests between 1500 and 2000 patients are needed | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Newborn infants admitted to normal newborn nursery
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| Name | Affiliation | Role |
|---|---|---|
| Vibeke Videm, MD, PhD | Norwegian University of Science and Technology, Instititue director | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Olavs University Hospital | Trondheim | N-7006 | Norway |
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| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D007567 | Jaundice, Neonatal |
| D006932 | Hyperbilirubinemia |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D012880 | Skin Pigmentation |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D000067029 | Physical Appearance, Body |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
| D010858 | Pigmentation |
| D010829 | Physiological Phenomena |
| D012879 | Skin Physiological Phenomena |
| D055827 | Integumentary System Physiological Phenomena |
| D001686 | Biological Phenomena |