Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population
NCT ID: NCT05623553
Last Updated: 2022-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
174 participants
INTERVENTIONAL
2018-07-01
2018-08-08
Brief Summary
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Detailed Description
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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..
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Newborn transferred to pediatric ward for any treatment
* Newborns who had received phototherapy.
0 Days
14 Days
ALL
Yes
Sponsors
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Norwegian University of Science and Technology Faculty of Medicine and Health Sciences Department of Public Health and Nursing
UNKNOWN
Hospital Materno- Infantil de Irapuato
UNKNOWN
Picterus AS
INDUSTRY
Responsible Party
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Principal Investigators
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Elisabeth Darj, Prof, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
NTNU Faculty of Medicine and Health Sciences, Department of Public Health and Nursing
Locations
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Hospital Materno- Infantil de Irapuato
Irapuato, Guanajuato, Mexico
Countries
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Related Links
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Master thesis describing the study and its results
Other Identifiers
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2018/1001
Identifier Type: -
Identifier Source: org_study_id
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