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| Name | Class |
|---|---|
| Stockholm South General Hospital | OTHER |
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A cross-sectional study at the Södersjukehuset facility (Stockholm, Sweden) collect data of newborns from a population with Neomar scale type 4 to adjust the algorithm of Picterus JP
To adjust Picterus JP to work in newborns with more pigmented skin, the investigators will collect a data set at Sachsska barnsjukhuset Södersjukhuset, Stockholm Sweden from 150 newborns with dark skins using Picterus JP, TcB, skin measurements from a spectrometer, visual assessment, and total serum bilirubin (TSB) levels. As a control, newborns with Neomar scale 1-3 will be included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enable high qualitative estimation of bilirubin levels in the blood of new-borns | Experimental | There is only one arm in this study which is to enable high qualitative estimation of bilirubin levels in the blood of new-borns with darker skin types using Picterus JP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Picterus Jaundice Pro | Device | Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enable high qualitative estimation of bilirubin levels in newborns, independent of skin color, using Picterus JP | Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with Neomar neonatal skin color scale type 4 (with type 1 being lower-melanin level and Type 4 being higher-melanin level) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Picterus-generated estimate with TsB | Compare bilirubin estimates calculated with the adjusted algoritm from the images with TSB measurements | 1-2 hours |
| Comparison of Picterus-generated estimate with TcB |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lobke Gierman, PhD | Picterus AS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södersjukhuset | Stockholm | 11883 | Sweden |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 2, 2024 | |
| Reset | Aug 22, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 2, 2024 | Aug 22, 2024 |
| ID | Term |
|---|---|
| D007567 | Jaundice, Neonatal |
| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
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Compare bilirubin estimates calculated with the adjusted algoritm from the images with TcB measurements
| 5-10min |
| Comparison of Picterus-generated estimate with visual assessment. | Compare bilirubin estimates calculated with the adjusted algoritm from the images with visual assessment. | 5-10min |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |