Intermountain Inpatient Bilirubin Decision Accuracy Study Using Smartphone-based Measurements by Picterus Jaundice Pro
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 8 days
Healthy Volunteers: t
View:
• the patient is free of skin rash, bruising, or other medical conditions that can interfere with transcutaneous measurement
• (preterm) \< = 35 weeks gestational age
• (term) \> 35 weeks gestational age
• the patient has not been excluded by PI discretion.
Locations
United States
Utah
Intermountain Health
RECRUITING
Salt Lake City
Contact Information
Primary
Timothy M Bahr, MS MD
Tim.Bahr@imail.org
801-602-6523
Backup
Kimberlee W Lewis, MS RN
kimberlee.weaverlewis@imail.org
801-507-7675
Time Frame
Start Date: 2024-02-12
Estimated Completion Date: 2024-05
Participants
Target number of participants: 500
Treatments
Term-born babies & preterm born babies
We will collect 300 paired (serum bilirubin and Picterus Jaundice Pro) measurements on eligible neonates \>35 weeks' gestation admitted to a well-baby nursery. Of these, 150 paired measurements will be from neonates who have already received phototherapy (either on phototherapy or status/post phototherapy) and had a light-occlusive adhesive skin patch in place. Each subject \>35 weeks gestation can have up to 5 measurements during the study.~We will collect 200 paired (serum bilirubin and Picterus) measurements on eligible neonates \<35 weeks gestation. Of these, 100 paired measurements will be from neonates who have already received phototherapy (either on phototherapy or status/post phototherapy) and had a light-occlusive adhesive skin patch in place. Each subject \<35 weeks gestation can have up to 5 measurements during the study.
Related Therapeutic Areas
Sponsors
Leads: Picterus AS
Collaborators: Intermountain Medical Center