Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia

Study Overview
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Brief Summary
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The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals: Demonstrate that Picterus system performs accurately in Indonesian newborns Ensure that Picterus is in line with users' needs in Indonesia

Detailed Description
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The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals: Demonstrate that Picterus system performs accurately in Indonesian newborns Ensure that Picterus is in line with users' needs in Indonesia

Official Title
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Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in 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 ≥37 weeks Birth weight ≥2000g and ≤4500g Age 1 - 14 days Exclusion Criteria: - Infants transferred to the pediatric ward for advanced treatment. Infants with a skin rash or other disease that affects the skin where measurements are performed. Infants that receive or have received phototherapy in the last 24 hours. Infants with an inborn disease

Ages Eligible for Study
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Minimum Age: 1 Day
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 and additionally measurements of skin color reflectance with a spectrophotometer, 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 of South-East Asian ethnicity and skin type. | Device: Picterus Jaundice Pro<br>* Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.<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 Indonesian newborns | Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns using Picterus JP. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation with TcB | Correlate the estimates of bilirubin levels obtained by Picterus with TcB | 5-10 minutes | 
| Correlation with Tsb and TcB | Correlate the estimates of bilirubin levels obtained by Picterus with TSB and TcB | 1-2 hours | 
| Picterus JP accuracy in Indonesian newborn | Determine the accuracy of Picterus in Indonesian newborns | 6 months |