NCT05521607

Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago)

Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice in Newborns with High Melanin Content (Chicago)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Picterus AS · Industry
• Sex: All
• Age: 1 Day – 14 Days
• Healthy volunteers: Accepted

Summary

A cross-sectional conductive study at the University of Chicago Medicine facilities (hospital and outreach clinics) to enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.

Detailed description

A cross-sectional conductive study at the University of Chicago Medicine facilities (hospital and outreach clinics) will be conducted to include a total of 250 newborns with a desired distribution of skin color according to Neomar's scale : skin color 1 and 2: 20%, skin color 3: 30% and skin color 4: 50%. Skin color may also be quantitatively assessed using a handheld spectrophotometer (CM-700d, Konica Minolta). The Picterus Calibration Card will be placed on the chest of the newborn with the hole in the card placed over the infant's chest. A validated smartphone with Picterus JP will be used to collect digital images, which are analysed to calculate a Picterus bilirubin value.

Conditions

• Neonatal Jaundice

Interventions

Type	Name	Description
DEVICE	Picterus Jaundice Pro (JP)	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: 2023-01-06
• Primary completion: 2024-10-31
• Completion: 2025-06-15
• First posted: 2022-08-30
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study