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Clinical Trials/NCT05623553
NCT05623553CompletedNot Applicable

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

Picterus AS2 sites in 1 country174 target enrollmentStarted: July 1, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
174
Locations
2
Primary Endpoint
Enable high qualitative estimation of bilirubin levels in the blood of newborns using Picterus JP
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

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
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
0 Days to 14 Days (Child)
Sex
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.

Outcomes

Primary Outcomes

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

  • Correlation with visual assessment(5-10 minutes)
  • Correlation with TsB(1-2 hours)
  • Correlation with TcB(5-10 minutes)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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