Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago)
Purpose
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.
Condition
- Neonatal Jaundice
Eligibility
- Eligible Ages
- Between 1 Day and 14 Days
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Infants born with gestational age > 35 weeks. - Birth weight ≥ 1800 grams - Age 1 - 14 days - Infants requiring a TSB blood sample for clinically suspected jaundice as part of standard care
Exclusion Criteria
- Infants showing signs of inborn disease. - Infants with skin rash or other skin disease that affects the skin where measurements are performed. - Infants transferred to the pediatric ward for medical treatment. - Infants that have received phototherapy in the last 24 hours
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Enable high qualitative estimation of bilirubin levels in the blood of new-borns |
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. |
|
Recruiting Locations
Chicago, Illinois 60637
More Details
- Status
- Recruiting
- Sponsor
- Picterus AS
Detailed Description
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.