Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population

Study Overview
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Brief Summary
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This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Dhulikhel Hospital, Kathmandu Nepal.

Detailed Description
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This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in 200 newborns at Dhulikhel Hospital, Kathmandu Nepal. 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 Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population at Dhulikhel Hospital, Kathmandu University Hospital.

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 ≥35 weeks Birth weight ≥ 1750g Age 1 - ≤14 days Infants that will have a blood sample draw Exclusion Criteria: Infants in the need for respiratory support Infants with conditions that could compromise skin circulation, as sepsis, heart failure Infants that have received phototherapy

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>There is only one arm in this study which is to enable high qualitative estimation of bilirubin levels in the blood of new-borns using Picterus JP. | 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 newborns, independent of skin color, using Picterus JP. | Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns at Dhulikhel Hospital, Kathmandu Nepal. | 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 hours | 
| 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 |