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

Recruiting

• Conditions: Neonatal Jaundice

• 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.

Study Timeline

• Study First Submitted: 2024-02-07
• Study Start: 2024-02-12
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-21
• Last Update Submitted: 2024-03-21
• Study First Posted: 2024-03-26
• Last Update Posted: 2024-03-26
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

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