Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia
NCT ID: NCT05623566
Last Updated: 2024-04-04
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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TERMINATED
NA
284 participants
INTERVENTIONAL
2018-11-29
2019-04-29
Brief Summary
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Detailed Description
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This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in Indonesian newborns. The Picterus Calibration Card was 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 was 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
In this study we aim to collect data of newborns with wider range of bilirubin levels to adjust the Picterus JP algorithm and optimize the app performance. This will enable a high qualitative estimation of bilirubin levels in the blood of new-borns for all skin colors.
Picterus Jaundice Pro
In this study we aim to collect data of newborns with wider range of bilirubin levels to adjust the Picterus JP algorithm and optimize the app performance. This will enable a high qualitative estimation of bilirubin levels in the blood of new-borns for all skin colors.
Interventions
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Picterus Jaundice Pro
In this study we aim to collect data of newborns with wider range of bilirubin levels to adjust the Picterus JP algorithm and optimize the app performance. This will enable a high qualitative estimation of bilirubin levels in the blood of new-borns for all skin colors.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Birth weight ≥ 1500g
* Age 0 - ≤14 days
* Consent obtained from the parents
Exclusion Criteria
* Infants respiratory support;
* Infants suffering from a condition that may alter the skin tissue circulatory system, such as sepsis and heart failure;
* Infants who have received phototherapy in the last 24 hours.
1 Hour
14 Days
ALL
Yes
Sponsors
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RSIA Kendangsaru Surabaya
UNKNOWN
Universitas Airlangga
OTHER
Picterus AS
INDUSTRY
Responsible Party
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Locations
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Airlangga University hospital
Surabaya, East Java, Indonesia
RSIA Kendangsari MERR
Surabaya, East Java, Indonesia
Dr. Soetomo General Hospital
Surabaya, East Java, Indonesia
Countries
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Other Identifiers
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2018/1608Indonesia
Identifier Type: -
Identifier Source: org_study_id
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