Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice in Newborns with High Melanin Content (Chicago)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Picterus AS
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 1 Day to 14 Days (Child)
- 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
Arms & Interventions
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.
Intervention: Picterus Jaundice Pro (JP) (Device)
Outcomes
Primary Outcomes
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
Time Frame: 3-6 months
Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.
Secondary Outcomes
- 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.(3-6 months)
- Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin.(3-6months)