NCT06329843

Intermountain Inpatient Bilirubin Decision Accuracy Study Using Smartphone-based Measurements by Picterus Jaundice Pro

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Picterus AS · Industry
• Sex: All
• Age: 12 Hours – 192 Hours
• Healthy volunteers: Accepted

Summary

The goal of this project is to evaluate the performance of Picterus Jaundice Pro in an American population, including preterm and term newborns and pre- and post- phototherapy.

Detailed description

The purpose of this study is to compare serum bilirubin levels with non-invasive bilirubin measurements in neonates during the first 12 to 192 hours of life using the "Picterus Jaundice Pro" smartphone application with a proprietary calibration card placed over the neonate's sternum. We will also validate the accuracy of Picterus Jaundice Pro bilirubin measurements before and after phototherapy treatment.

Conditions

• Neonatal Jaundice

Interventions

Type	Name	Description
DEVICE	Picterus Jaundice Pro (JP)	Picterus Jaundice Pro photos will be obtained of enrolled subjects each time the patient has a serum bilirubin level obtained. Up to five paired measurements will be obtained per enrolled subject. The study nurse will place the proprietary calibration card over the subject's sternum and take six Picterus Jaundice Pro photos using a study iPhone within one hour of the serum bilirubin draw. This process takes less than one minute. After the study photos are obtained, the study nurse will record the serum and Picterus Jaundice Pro values in the data-recording log. In the event an enrolled infant requires phototherapy, a light occlusive adhesive patch will be placed over the center of the chest before phototherapy initiation. When a serum bilirubin level is obtained, the research nurse will remove the patch for a brief moment to take Picterus Jaundice Pro pictures (within one hour of the serum value draw).

Timeline

• Start date: 2024-02-12
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2024-03-26
• Last updated: 2024-03-26

Locations

1 site across 1 country: United States