NCT05616845

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Picterus AS · Industry
• Sex: All
• Age: 1 Day – 14 Days
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Jaundice, Neonatal

Interventions

Type	Name	Description
DEVICE	Picterus Jaundice Pro	Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.

Timeline

• Start date: 2022-02-02
• Primary completion: 2022-02-26
• Completion: 2022-02-26
• First posted: 2022-11-15
• Last updated: 2022-11-23

Locations

1 site across 1 country: Philippines