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

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

Recruiting
1-14 years
All
Phase N/A

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Overview

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.

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%. The Picterus Calibration Card will be placed on the chest of the newborn with the hole in the card placed over the infant's sternum. A validated smartphone with Picterus JP will be used to collect digital images..

Eligibility

Inclusion Criteria:

  • Infants born with gestational age > 37 weeks.
  • Birth weight ≥ 2500 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 details
    Neonatal Jaundice

NCT05521607

Picterus AS

4 May 2024

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