Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones
NCT ID: NCT05955144
Last Updated: 2023-07-21
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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UNKNOWN
NA
100 participants
INTERVENTIONAL
2022-10-01
2024-12-01
Brief Summary
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Detailed Description
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Picterus JP bilirubin estimates from a Samsung S7 will be compared with three smartphones with different camera types and a TcB measurement The clinical outcomes will be compared to our camera validation systems. Skin color measurements using a spectrophotometer will be used for technical optimization of the camera validation system
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Repeatable bilirubin measurement independent of phone
all subjects will receive bilirubin measurement from 4 different smartphones and a transcutaneous device to ensure that the measurement of bilirubin is not affected by phone camera
Picterus JP
Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is placed.
Interventions
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Picterus JP
Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is placed.
Eligibility Criteria
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Inclusion Criteria
* Birth weight ≥ 2500 grams
* Age 1 - 14 days
Exclusion Criteria
* Infants with skin rash or other skin disease that affects the skin where measurements are performed.
* Infants transferred to the pediatric ward for medical treatment.
* Infants that have received phototherapy in the last 24 hours
1 Day
14 Days
ALL
Yes
Sponsors
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Picterus AS
INDUSTRY
Responsible Party
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Locations
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St Olav Hospital
Trondheim, , Norway
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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allphone
Identifier Type: -
Identifier Source: org_study_id
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