Intermountain Inpatient Bilirubin Decision Accuracy Study Using Smartphone-based Measurements by Picterus Jaundice Pro
- Conditions
- Neonatal Jaundice
- Interventions
- Device: Picterus Jaundice Pro (JP)
- Registration Number
- NCT06329843
- Lead Sponsor
- Picterus AS
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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.
- Neonates will be excluded from participation if all four inclusion criteria listed above are not met.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Term-born babies & preterm born babies Picterus Jaundice Pro (JP) 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.
- Primary Outcome Measures
Name Time Method Enable high qualitative estimation of bilirubin levels in the blood of term and preterm newborns undergoing phototherapy using Picterus JP. 2 months Evaluate Picterus JP to screen for neonatal jaundice in term and preterm newborns undergoing phototherapy and use the results to improve the analysis algorithm for this population
- Secondary Outcome Measures
Name Time Method Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies without phototherapy. 2 hours Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in preterm-born babies without phototherapy.
Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies who have received phototherapy. 2 hours Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in preterm-born babies who have received phototherapy.
Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies without phototherapy. 2 hours Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in term-born babies without phototherapy.
Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies who have received phototherapy. 2 hours Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in term-born babies who have received phototherapy.
Trial Locations
- Locations (1)
Intermountain Health
🇺🇸Salt Lake City, Utah, United States