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

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

Study Overview

• Status: Completed
• Conditions: Jaundice, Neonatal
• Intervention / Treatment: Device: Picterus Jaundice Pro

Detailed Description

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
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Guanajuato
    • Irapuato, Guanajuato, Mexico, 36546
      • Hospital Materno- Infantil de Irapuato

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Picterus Jaundice Pro; Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.; Other Names: Picterus JP

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Picterus AS
• Collaborators: Norwegian University of Science and Technology Faculty of Medicine and Health Sciences Department of Public Health and Nursing; Hospital Materno- Infantil de Irapuato
• Investigators: Principal Investigator: Elisabeth Darj, Prof, MD, PhD, NTNU Faculty of Medicine and Health Sciences, Department of Public Health and Nursing

Publications and helpful links

Helpful Links

• Master thesis describing the study and its results

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): July 11, 2018
• Study Completion (Actual): August 8, 2018

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice; Jaundice, Neonatal
• Other Study ID Numbers: 2018/1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No