Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chica
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(s) | Neonatal Jaundice |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 |
| Ages | 1 Day to 14 Days |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Picterus AS |
| Locations | Chicago, Illinois, United States |
| Start date | 2023-01-06 |
| NCT ID | NCT05521607 |
| Official listing | https://clinicaltrials.gov/study/NCT05521607 |