Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia

Study Overview
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Brief Summary
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A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns in Surabaya.

Detailed Description
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A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Airlangga University hospital and RSIA Kendangsari MERR in Surabaya. 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.

Official Title
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Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia

Conditions
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Jaundice, Neonatal

Intervention / Treatment
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* Device: Picterus Jaundice Pro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants born with gestational age >31 Birth weight ≥ 1500g Age 0 - ≤14 days Consent obtained from the parents Exclusion Criteria: Infants born with congenital abnormalities; 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.

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enable high qualitative estimation of bilirubin levels in the blood of new-borns<br>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. | Device: Picterus Jaundice Pro<br>* 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.<br>* Other names: Picterus JP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP. | Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in Indonesian newborns. | 5-10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn | To evaluate the correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice | 1-2 minutes | 
| correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns | To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns with varying degree of jaundice | 5-10 minutes | 
| Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns | To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice | 5-10 minutes |