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Completed

NCT Number: NCT05623553

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.

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Key information

Conditions

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

Age range

0 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Materno- Infantil de Irapuato

Irapuato, Guanajuato, 36546, Mexico

About this study

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..

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Picterus JP

Primary outcomes

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

    Time frame: 6 months

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

Secondary outcomes

  1. Correlation with TsB

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Picterus AS

Industry

Collaborators

  • Hospital Materno- Infantil de Irapuato
  • Norwegian University of Science and Technology

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 21, 2022
Registry last updated
Nov 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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