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

NCT06329843 | Recruiting

• 1 other identifier: Intermountain
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Jaundice

Keywords

jaundice; neonate; phototherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies without phototherapy.

  2 hours

• Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from 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.

  2 hours

• Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies who have received phototherapy.

  2 hours

Study Arms (1)

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)

Interventions

Picterus Jaundice Pro (JP) DEVICE

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).

Term-born babies & preterm born babies

Eligibility Criteria

• Age: 12 Hours - 192 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

newborns

You may qualify if:

• 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.

Sponsors & Collaborators

• Picterus AS: lead
• Intermountain Medical Center: collaborator

Study Sites (1)

Intermountain Health

Salt Lake City, Utah, 84132, United States

RECRUITING

MeSH Terms

Conditions

Jaundice, Neonatal; Jaundice

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Timothy M Bahr, MS MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy M Bahr, MS MD

CONTACT

801-602-6523; Tim.Bahr@imail.org

Kimberlee W Lewis, MS RN

CONTACT

801-507-7675; kimberlee.weaverlewis@imail.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: March 26, 2024
• Study Start: February 12, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

US (1)