Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago)

Last updated: September 13, 2024
Sponsor: Picterus AS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Primary Biliary Cholangitis

Liver Disease

Treatment

Picterus Jaundice Pro (JP)

Clinical Study ID

NCT05521607
IRB22-0480
  • Ages 1-14
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 ofstandard care

Exclusion

Exclusion Criteria:

  • Infants showing signs of inborn disease.

  • Infants with skin rash or other skin disease that affects the skin wheremeasurements are performed.

  • Infants transferred to the pediatric ward for medical treatment.

  • Infants that have received phototherapy in the last 24 hours

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Picterus Jaundice Pro (JP)
Phase:
Study Start date:
January 06, 2023
Estimated Completion Date:
June 15, 2025

Study 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.

Connect with a study center

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

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