Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns

Study Overview
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Brief Summary
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A cross-sectional study at the Södersjukehuset facility (Stockholm, Sweden) collect data of newborns from a population with Neomar scale type 4 to adjust the algorithm of Picterus JP

Detailed Description
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To adjust Picterus JP to work in newborns with more pigmented skin, the investigators will collect a data set at Sachsska barnsjukhuset Södersjukhuset, Stockholm Sweden from 150 newborns with dark skins using Picterus JP, TcB, skin measurements from a spectrometer, visual assessment, and total serum bilirubin (TSB) levels. As a control, newborns with Neomar scale 1-3 will be included.

Official Title
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Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns

Conditions
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Jaundice, Neonatal

Intervention / Treatment
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* Device: Picterus Jaundice Pro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants born with gestational age ≥ 37 Birth weight ≥ 2500g Age 1 - 14 days Will have a blood sample performed, either for clinically suspected jaundice or newborn screening sample Exclusion Criteria: Infants showing signs of inborn disease Infants transferred to pediatric ward for treatment Infants that have received phototherapy

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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 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 with darker skin types using Picterus JP. | Device: Picterus Jaundice Pro<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 newborns, independent of skin color, using Picterus JP | Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with Neomar neonatal skin color scale type 4 (with type 1 being lower-melanin level and Type 4 being higher-melanin level) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Picterus-generated estimate with TsB | Compare bilirubin estimates calculated with the adjusted algoritm from the images with TSB measurements | 1-2 hours | 
| Comparison of Picterus-generated estimate with TcB | Compare bilirubin estimates calculated with the adjusted algoritm from the images with TcB measurements | 5-10min | 
| Comparison of Picterus-generated estimate with visual assessment. | Compare bilirubin estimates calculated with the adjusted algoritm from the images with visual assessment. | 5-10min |