NCT05365399

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Picterus AS · Industry
• Sex: All
• Age: 24 Hours – 14 Days
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Neonatal Jaundice

Interventions

Type	Name	Description
DEVICE	smartphone-based screening tool for neonatal jaundice	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. .

Timeline

• Start date: 2022-05-03
• Primary completion: 2022-08-15
• Completion: 2022-08-15
• First posted: 2022-05-09
• Last updated: 2024-04-04

Locations

1 site across 1 country: Uganda