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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
| University Hospital, Akershus | OTHER |
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Neonatal jaundice is a common and most often harmless condition. However, when unrecognized it can be fatal or cause serious brain injury. Three quarters of these deaths are estimated to occur in the poorest regions of the world. The treatment of jaundice, phototherapy, is in most cases easy, low-cost and harmless. The crucial point in reducing the burden of disease is therefore to identify then children at risk. This results in the need for low-cost, reliable and easy-to-use diagnostic tools that can identify newborns with jaundice.
Based on previous research on the bio-optics of jaundiced newborn skin, a prototype of a smartphone application has been developed. This prototype will be evaluated in a clinical trial in two hospitals in Norway. A smartphone will be used to take picture of the skin of the newborn, and by using an algorithm an estimate of the bilirubin concentration is made. The results from these estimates will be compared to the bilirubin levels measured in standard blood samples, as well as the results from ordinary transcutaneous measurement devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| newborn infants checked for jaundice | Experimental | an experimental way of bilirubin concentration estimation from smartphone pictures is applied and compared with two standard methods: bilirubin concentration measured in standard blood samples, and bilirubin concentration measured by transcutaneous device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bilirubin concentration estimation from smartphone pictures | Device | pictures taken of the skin covering the breast bone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between bilirubin estimates by smartphone pictures and by blood samples | Estimate of bilirubin levels from smartphone pictures, compared with bilirubin measurement in blood samples in a correlation study. Correlation will be expressed by Pearson correlation coefficient, r. | 5 minutes |
| Correlation between bilirubin estimates by smartphone pictures and by transcutaneous measurements | Estimate of bilirubin levels from smartphone pictures, compared with bilirubin measurements from transcutaneous devices in a correlation study. Correlation will be expressed by Pearson correlation coefficient, r. | 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siri Forsmo, md prof | Norwegian University of Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Oslo | Norway | ||||
| St Olavs Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32267569 | Result | Aune A, Vartdal G, Bergseng H, Randeberg LL, Darj E. Bilirubin estimates from smartphone images of newborn infants' skin correlated highly to serum bilirubin levels. Acta Paediatr. 2020 Dec;109(12):2532-2538. doi: 10.1111/apa.15287. Epub 2020 Apr 19. |
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| bilirubin concentration measured in standard blood samples | Procedure |
|
| bilirubin concentration measured by transcutaneous device | Device |
|
| Trondheim |
| Norway |
| ID | Term |
|---|---|
| D007567 | Jaundice, Neonatal |
| D051556 | Hyperbilirubinemia, Neonatal |
| D004194 | Disease |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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