Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago)
NCT ID: NCT05521607
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2023-01-06
2025-06-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
1 Day
14 Days
ALL
Yes
Sponsors
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University of Chicago
OTHER
Picterus AS
INDUSTRY
Responsible Party
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Principal Investigators
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Jeanmarie Schied, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB22-0480
Identifier Type: -
Identifier Source: org_study_id
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