Actively Recruiting
Evaluation of a Smartphone-Based Screening Tool Picterus JP for Neonatal Jaundice in Newborns with High Melanin Content
Led by Picterus AS · Updated on 2024-09-19
250
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
Sponsors
P
Picterus AS
Lead Sponsor
U
University of Chicago
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a smartphone-based screening tool called Picterus JP to estimate bilirubin levels in newborns' blood regardless of skin color. This study will take place at the University of Chicago Medicine facilities, including hospital and outreach clinics, and aims to include 250 newborns with a range of skin colors. The study seeks to improve bilirubin measurement especially in newborns with high melanin content in the skin. The study involves placing the Picterus Calibration Card on the newborn's chest and using a validated smartphone app, Picterus Jaundice Pro, to take digital images of the skin. These images will be analyzed to calculate bilirubin levels. The study has a single intervention arm focused on assessing the Picterus JP device's ability to estimate bilirubin qualitatively in newborns. Participants will be newborns aged 1 to 14 days who require a TSB blood sample for suspected jaundice as part of their standard care. Researchers will collect images and compare Picterus JP bilirubin estimates with standard tests such as total serum bilirubin and transcutaneous bilirubin. The study will monitor accuracy, adapt the algorithm for skin melanin content, and measure outcomes over 3 to 6 months. The participation involves imaging, clinical data collection, and follow-up assessments.
CONDITIONS
Brief Title
Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Infants showing signs of inborn disease
- Infants with skin rash or other skin disease affecting the measurement area
- Infants transferred to the pediatric ward for medical treatment
- Infants that have received phototherapy in the last 24 hours
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 1 day
Participants undergo evaluation using the Picterus Jaundice Pro smartphone app to estimate bilirubin levels in newborns with high melanin content in the skin.
1 visit (in-person) for digital image collection and bilirubin estimation
Duration - 3 to 6 months
Participants are monitored to assess the accuracy and adaptation of the Picterus JP algorithm over a period of 3 to 6 months.
Follow-up assessments may occur as part of routine care
Trial Site Locations
Total: 1 location
1
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
J
Jeanmarie Schied, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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