A mHealth Application as a Screening Tool for Neonatal Jaundice in Filipino Neonates

Study Overview
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Brief Summary
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The purpose of the study is to test the reliability of the Picterus smartphone application in Filipino neonates. A descriptive cross-sectional study will be the method to understand the correlation of the modalities and to determine the reliability of the application

Detailed Description
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The purpose of the study is to test the reliability of the Picterus smartphone application. The study is designed for Filipino neonates, but implemented in other LMIC. The participants include newborns with or without jaundice, Gestational age >37 weeks, Age0-14days, Weight >2500 gram and absence of congenital malformations. Demographic data of the neonates will be collected together with all the performed tests and it will be stored in a secured system. Blood will be drawn and measure the bilirubin level of the neonates in a standard clinical routine and will be compared to the estimated bilirubin performed with the Picterus smartphone application. A descriptive cross-sectional study will be the method to understand the correlation of the modalities and to determine the reliability of the application. It will provide an answer to whether the Picterus smartphone application is reliable to other populations, especially to darker skin and with high melanin content such as Filipino neonates.

Official Title
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A mHealth Application as a Screening Tool for Neonatal Jaundice in Filipino Neonates

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: Newborns with or without jaundice Gestational age ≥ 37 weeks Age 0 - 14 days Weight 2500 to 4500 grams Absence of congenital malformations Exclusion Criteria: Newborns with life-threatening conditions or significant illness Newborns diagnosed with inborn errors of metabolism Jaundiced newborns that have undergone phototherapy before screening

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 with darker skin and with high melanin content such as Filipino neonates. | 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 |
| --- | --- | --- |
| validate the reliability of the Picterus mHealth application as a screening tool for neonatal jaundice in Filipino neonates | Validation of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content. | 5-10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between the estimated levels of bilirubin detected by the Picterus mHealth application and bilirubin serum levels in Filipino neonates | correlation between the estimated levels of bilirubin detected by the Picterus mHealth application and bilirubin serum levels in Filipino neonates | 1-2 hours | 
| correlation between the estimated level of bilirubin detected by the Picterus mHealth application and transcutaneous bilirubinometer results in Filipino neonates. | correlation between the estimated level of bilirubin detected by the Picterus mHealth application and transcutaneous bilirubinometer results in Filipino neonates. | 5-10 minutes | 
| correlation between the estimated level of bilirubin detected by the Picterus mHealth application and those obtained using visual Kramer scale in Filipino neonates. | correlation between the estimated level of bilirubin detected by the Picterus mHealth application and those obtained using visual Kramer scale in Filipino neonates. | 5 minutes | 
| sensitivity, specificity, positive and negative predictive value between estimated bilirubin level of the digital images, Kramer examination and TcB. | sensitivity, specificity, positive and negative predictive value between estimated bilirubin level of the digital images, Kramer examination and TcB. | 5 months |