Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Chicago | OTHER |
Not provided
Not provided
A cross-sectional conductive study at the University of Chicago Medicine facilities (hospital and outreach clinics) to enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
A cross-sectional conductive study at the University of Chicago Medicine facilities (hospital and outreach clinics) will be conducted to include a total of 250 newborns with a desired distribution of skin color according to Neomar's scale : skin color 1 and 2: 20%, skin color 3: 30% and skin color 4: 50%. Skin color may also be quantitatively assessed using a handheld spectrophotometer (CM-700d, Konica Minolta).
The Picterus Calibration Card will be placed on the chest of the newborn with the hole in the card placed over the infant's chest. A validated smartphone with Picterus JP will be used to collect digital images, which are analysed to calculate a Picterus bilirubin value.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enable high qualitative estimation of bilirubin levels in the blood of new-borns | Other | 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 (JP) | 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, independent of skin color, using Picterus JP. | Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content. | 3-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin. | Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin. | 3-6months |
| Correlate estimates of bilirubin levels obtained by Picterus JP with TSB, TcB and VA in newborns with high melanin content in the skin. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeanmarie Schied, MD | Contact | 7737029200 | jschied@peds.bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeanmarie Schied, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007567 | Jaundice, Neonatal |
| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Correlate estimates of bilirubin levels obtained by Picterus JP with TSB, TcB and VA in newborns with high melanin content in the skin. |
| 3-6 months |
| Determine the accuracy of Picterus JP in newborns with high melanin content in the skin. | Determine the accuracy of Picterus JP in newborns with high melanin content in the skin. | 3-6 months |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |