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 in Newborns with High Melanin Content (Chicago)

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.

Study Overview

• Status: Recruiting
• Conditions: Neonatal Jaundice
• Intervention / Treatment: Device: Picterus Jaundice Pro (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 Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeanmarie Schied, MD; Phone Number: 7737029200; Email: jschied@peds.bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: Jeanmarie Schied, MD; Phone Number: 7737029200; Email: jschied@peds.bsd.uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 weeks (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: Picterus Jaundice Pro (JP); Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.	Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.	3-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin.	Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin.	3-6months
Correlate estimates of bilirubin levels obtained by Picterus JP with TSB, TcB and VA in newborns with high melanin content in the skin.	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.	Determine the accuracy of Picterus JP in newborns with high melanin content in the skin.	3-6 months

Collaborators and Investigators

• Sponsor: Picterus AS
• Collaborators: University of Chicago
• Investigators: Principal Investigator: Jeanmarie Schied, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice; Jaundice, Neonatal
• Other Study ID Numbers: IRB22-0480

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No