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

Neonatal Jaundice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06329843
• Other study ID #: Intermountain
• Status: Recruiting
• Start date: February 12, 2024
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: Picterus AS
• Contact: Timothy M Bahr, MS MD
• Phone: 801-602-6523
• Email: Tim.Bahr[@]imail.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Hours to 192 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Neonatal
• Neonatal Jaundice

Intervention

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).

Locations

Country	Name	City	State
United States	Intermountain Health	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Picterus AS	Intermountain Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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