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

Picterus AS174 enrolled

Overview

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

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..

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

174

Conditions

Jaundice, Neonatal

Interventions

Picterus Jaundice ProDEVICE

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

Sex: ALLMin age: 0 DaysMax age: 14 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Materno- Infantil de Irapuato

Irapuato, Guanajuato, Mexico

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 5-10 minutes

Data from ClinicalTrials.gov

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