- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05521607
Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago)
April 16, 2024 updated by: Picterus AS
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
Intervention / Treatment
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..
Study Type
Interventional
Enrollment (Estimated)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jeanmarie Schied, MD
- Phone Number: 7737029200
- Email: jschied@peds.bsd.uchicago.edu
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago
-
Contact:
- Jeanmarie Schied, MD
- Phone Number: 773-702-9200
- Email: jschied@peds.bsd.uchicago.edu
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 2 weeks (Child)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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.
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Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.
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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.
Time Frame: 3-6 months
|
Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.
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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.
Time Frame: 3-6months
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Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin.
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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.
Time Frame: 3-6 months
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Correlate estimates of bilirubin levels obtained by Picterus JP with TSB, TcB and VA in newborns with high melanin content in the skin.
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3-6 months
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Determine the accuracy of Picterus JP in newborns with high melanin content in the skin.
Time Frame: 3-6 months
|
Determine the accuracy of Picterus JP in newborns with high melanin content in the skin.
|
3-6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeanmarie Schied, MD, University of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 6, 2023
Primary Completion (Estimated)
June 15, 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)
April 17, 2024
Last Update Submitted That Met QC Criteria
April 16, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB22-0480
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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