Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population

Study Overview
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Brief Summary
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The general objective of this study is to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at HICH Mbarara. The specific objectives for this study are: To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice 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 To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice

Official Title
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Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population

Conditions
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Neonatal Jaundice

Intervention / Treatment
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* Device: smartphone-based screening tool for neonatal jaundice


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 Infants requiring a blood sample (newborn screening / clinically suspected jaundice) Exclusion Criteria: Infants transferred to the paediatric 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: 24 Hours
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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 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 high melanin content, 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 for all skin colors. . | Device: smartphone-based screening tool for neonatal jaundice<br>* In this study we aim to collect data of newborns with wider range of bilirubin levels and high melanin content, 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 for all skin colors. .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smartphone application sensitivity (bilirubin levels on newborns) | Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smartphone application sensitivity (bilirubin levels on newborns with high melanin content) in the skin. | Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP. Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin | 5 minutes |