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

NCT05521607 | Recruiting FDA Device

• 1 other identifier: IRB22-0480
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neonatal Jaundice

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

  3-6 months

• Determine the accuracy of Picterus JP in newborns with high melanin content in the skin.

  3-6 months

Study Arms (1)

Enable high qualitative estimation of bilirubin levels in the blood of new-borns

OTHER

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)

Interventions

Picterus Jaundice Pro (JP) DEVICE

Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.

Enable high qualitative estimation of bilirubin levels in the blood of new-borns

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Picterus AS: lead
• University of Chicago: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeanmarie Schied, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeanmarie Schied, MD

CONTACT

7737029200; jschied@peds.bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 30, 2022
• Study Start: January 6, 2023
• Primary Completion: October 31, 2024
• Study Completion: June 15, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)