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

Sponsor
Picterus AS (Industry)
Overall Status
Completed
CT.gov ID
NCT05623553
Collaborator
Norwegian University of Science and Technology Faculty of Medicine and Health Sciences Department of Public Health and Nursing (Other), Hospital Materno- Infantil de Irapuato (Other)
174
Enrollment
1
Location
1
Arm
1.2
Actual Duration (Months)
139.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Picterus Jaundice Pro
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
174 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population
Actual Study Start Date :
Jul 1, 2018
Actual Primary Completion Date :
Jul 11, 2018
Actual Study Completion Date :
Aug 8, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Enable high qualitative estimation of bilirubin levels in the blood of newborns using Picterus JP [6 months]

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

    Secondary Outcome Measures

    1. Correlation with TsB [1-2 hours]

      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.

    2. Correlation with TcB [5-10 minutes]

      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.

    3. Correlation with visual assessment [5-10 minutes]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Days to 14 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Materno- Infantil de Irapuato Irapuato Guanajuato Mexico 36546

    Sponsors and Collaborators

    • Picterus AS
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Picterus AS
    ClinicalTrials.gov Identifier:
    NCT05623553
    Other Study ID Numbers:
    • 2018/1001
    First Posted:
    Nov 21, 2022
    Last Update Posted:
    Nov 21, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Jaundice, Neonatal
    Jaundice

    Study Results

    No Results Posted as of Nov 21, 2022