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

NCT06329843 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-03-26

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Intermountain Medical Center

    collaborator OTHER

  • Picterus AS

    lead INDUSTRY

Principal Investigators

  • Timothy M Bahr, MS MD · Intermountain Health Care, Inc.

Eligibility

Min Age
12 Hours
Max Age
192 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-12
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06329843 on ClinicalTrials.gov