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

NCT05623553 | Completed

• 1 other identifier: 2018/1001
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Jaundice, Neonatal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlation with TsB

  1-2 hours

• Correlation with TcB

  5-10 minutes

• Correlation with visual assessment

  5-10 minutes

Study Arms (1)

Enable high qualitative estimation of bilirubin levels in the blood of new-borns

EXPERIMENTAL

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

Interventions

Picterus Jaundice Pro DEVICE

Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.

Also known as: Picterus JP

Enable high qualitative estimation of bilirubin levels in the blood of new-borns

Eligibility Criteria

• Age: 0 Days - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Newborns showing signs or with diagnosis of inborn diseases
• Newborn transferred to pediatric ward for any treatment
• Newborns who had received phototherapy.

Sponsors & Collaborators

• Picterus AS: lead
• Hospital Materno- Infantil de Irapuato: collaborator
• Norwegian University of Science and Technology Faculty of Medicine and Health Sciences Department of Public Health and Nursing: collaborator

Study Sites (1)

Hospital Materno- Infantil de Irapuato

Irapuato, Guanajuato, 36546, Mexico

Location

Related Links

• Master thesis describing the study and its results

MeSH Terms

Conditions

Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elisabeth Darj, Prof, MD, PhD

  NTNU Faculty of Medicine and Health Sciences, Department of Public Health and Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 21, 2022
• Study Start: July 1, 2018
• Primary Completion: July 11, 2018
• Study Completion: August 8, 2018
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)