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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
| Hospital Materno- Infantil de Irapuato | UNKNOWN |
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This corss-sectional study aims to test the performance and accuracy of the Picterus JP screening device in newborns with different skin types.
A descriptive cross-sectional study among 174 newborns was carried out at Hospital Materno-Infantil de Irapuato in Mexico during July and August 2018.
The Picterus Calibration Card will be placed on the chest of the newborn with the hole in the card placed over the infant's sternum. A validated smartphone with Picterus JP will be used to collect digital images..
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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, independent of skin color, 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 the blood of newborns using Picterus JP | Evaluate of smartphone-based diagnostic tool (Picterus JP) for neonatal jaundice in newborns. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation with TsB | Demonstrate the correlation among the estimated levels of bilirubin obtained through a smartphone based diagnostic tool with bilirubin serum levels in a population of Mexican neonates. | 1-2 hours |
| Correlation with TcB |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Darj, Prof, MD, PhD | NTNU Faculty of Medicine and Health Sciences, Department of Public Health and Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Materno- Infantil de Irapuato | Irapuato | Guanajuato | 36546 | Mexico |
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| Label | URL |
|---|---|
| Master thesis describing the study and its results | View source |
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| 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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|
Demonstrate the correlation among the estimated levels of bilirubin obtained through a smartphone based diagnostic tool with those obtained using a transcutaneous bilirubinometer in a population of Mexican neonates.
| 5-10 minutes |
| Correlation with visual assessment | Demonstrate the correlation among the estimated levels of bilirubin obtained through a smartphone based diagnostic tool with those obtained using visual Kramer scale in a population of Mexican neonates. | 5-10 minutes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |