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

Picterus

Status: Completed

Conditions: Jaundice, Neonatal

Treatments: Device: Picterus Jaundice Pro

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05623553

2018/1001

Details and patient eligibility

About

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

Full 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..

Enrollment: 174 patients

Sex: All

Ages: Under 14 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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174 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Device: Picterus Jaundice Pro