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

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.

Study Overview

• Status: Recruiting
• Conditions: Neonatal Jaundice
• Intervention / Treatment: Device: Picterus Jaundice Pro (JP)

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Timothy M Bahr, MS MD; Phone Number: 801-602-6523; Email: Tim.Bahr@imail.org
• Study Contact Backup: Name: Kimberlee W Lewis, MS RN; Phone Number: 801-507-7675; Email: kimberlee.weaverlewis@imail.org

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • Intermountain Health
      • Contact: Timothy M Bahr, MS MD; Phone Number: 801-602-6523; Email: Tim.Bahr@imail.org
      • Contact: Kimberlee W Lewis, MS RN; Phone Number: 801.507.7675; Email: [kimberlee.weaverlewis@imail.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

newborns

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enable high qualitative estimation of bilirubin levels in the blood of term and preterm newborns undergoing phototherapy using Picterus JP.	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	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies without phototherapy.	Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in term-born babies without phototherapy.	2 hours
Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies without phototherapy.	Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in preterm-born babies without phototherapy.	2 hours
Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies who have received phototherapy.	Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in term-born babies who have received phototherapy.	2 hours
Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies who have received phototherapy.	Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in preterm-born babies who have received phototherapy.	2 hours

Collaborators and Investigators

• Sponsor: Picterus AS
• Collaborators: Intermountain Medical Center
• Investigators: Principal Investigator: Timothy M Bahr, MS MD, Intermountain Health Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: phototherapy; neonate; jaundice
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice; Jaundice, Neonatal
• Other Study ID Numbers: Intermountain

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No