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

Primary Purpose

Neonatal Jaundice

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Picterus Jaundice Pro (JP)
Sponsored by
Picterus AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neonatal Jaundice

Eligibility Criteria

1 Day - 14 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of ChicagoRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 22, 2022
Last Updated
March 30, 2023
Sponsor
Picterus AS
Collaborators
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05521607
Brief Title
Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago)
Official Title
Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice in Newborns With High Melanin Content (Chicago)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2023 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
June 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Picterus AS
Collaborators
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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%. 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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Jaundice

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enable high qualitative estimation of bilirubin levels in the blood of new-borns
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Picterus Jaundice Pro (JP)
Intervention Description
Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.
Primary Outcome Measure Information:
Title
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
Description
Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.
Time Frame
3-6 months
Secondary Outcome Measure Information:
Title
Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin.
Description
Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin.
Time Frame
3-6months
Title
Correlate estimates of bilirubin levels obtained by Picterus JP with TSB, TcB and VA in newborns with high melanin content in the skin.
Description
Correlate estimates of bilirubin levels obtained by Picterus JP with TSB, TcB and VA in newborns with high melanin content in the skin.
Time Frame
3-6 months
Title
Determine the accuracy of Picterus JP in newborns with high melanin content in the skin.
Description
Determine the accuracy of Picterus JP in newborns with high melanin content in the skin.
Time Frame
3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanmarie Schied, MD
Phone
7737029200
Email
jschied@peds.bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanmarie Schied, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanmarie Schied, MD
Phone
773-702-9200
Email
jschied@peds.bsd.uchicago.edu

12. IPD Sharing Statement

Learn more about this trial

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

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