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

Study Overview
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Brief Summary
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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
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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..

Official Title
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Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice in Newborns With High Melanin Content (Chicago)

Conditions
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Neonatal Jaundice

Intervention / Treatment
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* Device: Picterus Jaundice Pro (JP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention 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<br>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)<br>* Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.<br>|

What is the study measuring?
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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 |