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NCT05521607NARecruitingAccepts Healthy Volunteers

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

Picterus AS

Start Date

1/6/2023

Completion Date

6/15/2025

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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

Interventions

DEVICE

Picterus Jaundice Pro (JP)

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Conditions

Neonatal Jaundice

Locations

University of Chicago

Chicago, Illinois 60637

United States