Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population

Study Overview
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Brief Summary
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This corss-sectional study aims to test the performance and accuracy of the Picterus JP screening device in newborns with different skin types.

Detailed Description
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A descriptive cross-sectional study among 174 newborns was carried out at Hospital Materno-Infantil de Irapuato in Mexico during July and August 2018. 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 Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population

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: Healthy newborns with or without signs of jaundice Gestational age >35 weeks Age 0-14 days Birth weight > 1500 g. Parents acceptance of their children to participate in the study. Newborn needing a blood test Exclusion Criteria: Newborns showing signs or with diagnosis of inborn diseases Newborn transferred to pediatric ward for any treatment Newborns who had received phototherapy.

Ages Eligible for Study
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Minimum Age: 0 Days
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, independent of skin color, 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>* Other names: Picterus JP;|

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 using Picterus JP | Evaluate of smartphone-based diagnostic tool (Picterus JP) for neonatal jaundice in newborns. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation with TsB | Demonstrate the correlation among the estimated levels of bilirubin obtained through a smartphone based diagnostic tool with bilirubin serum levels in a population of Mexican neonates. | 1-2 hours | 
| Correlation with TcB | Demonstrate the correlation among the estimated levels of bilirubin obtained through a smartphone based diagnostic tool with those obtained using a transcutaneous bilirubinometer in a population of Mexican neonates. | 5-10 minutes | 
| Correlation with visual assessment | Demonstrate the correlation among the estimated levels of bilirubin obtained through a smartphone based diagnostic tool with those obtained using visual Kramer scale in a population of Mexican neonates. | 5-10 minutes |