A mHealth Application as a Screening Tool for Neonatal Jaundice in Filipino Neonates
NCT ID: NCT05616845
Last Updated: 2022-11-23
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
69 participants
INTERVENTIONAL
2022-02-02
2022-02-26
Brief Summary
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Detailed Description
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The study is designed for Filipino neonates, but implemented in other LMIC. The participants include newborns with or without jaundice, Gestational age \>37 weeks, Age0-14days, Weight \>2500 gram and absence of congenital malformations. Demographic data of the neonates will be collected together with all the performed tests and it will be stored in a secured system. Blood will be drawn and measure the bilirubin level of the neonates in a standard clinical routine and will be compared to the estimated bilirubin performed with the Picterus smartphone application.
A descriptive cross-sectional study will be the method to understand the correlation of the modalities and to determine the reliability of the application.
It will provide an answer to whether the Picterus smartphone application is reliable to other populations, especially to darker skin and with high melanin content such as Filipino neonates.
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 with darker skin and with high melanin content such as Filipino neonates.
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 ≥ 37 weeks
* Age 0 - 14 days
* Weight 2500 to 4500 grams
* Absence of congenital malformations
Exclusion Criteria
* Newborns diagnosed with inborn errors of metabolism
* Jaundiced newborns that have undergone phototherapy before screening
1 Day
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
Gov. Celestino Gallares Memorial Hospital
UNKNOWN
Picterus AS
INDUSTRY
Responsible Party
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Principal Investigators
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Jon Øyvind Odland, Prof,MD,PhD
Role: STUDY_DIRECTOR
NTNU Faculty of Medicine and Health Sciences, Department of Public Health and Nursing
Locations
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Governor Celestino Gallares Memorial Hospital
Tagbilaran City, Bohol, Philippines
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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322016
Identifier Type: -
Identifier Source: org_study_id
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