Evaluating smartphone bilirubin measurements in newborns
Intermountain Inpatient Bilirubin Decision Accuracy Study Using Smartphone-based Measurements by Picterus Jaundice Pro
This study is testing a smartphone app that measures bilirubin levels in newborns to see if it works as well as traditional blood tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 12 Hours to 192 Hours |
| Sex | All |
| Sponsor | Picterus AS Industry-sponsored |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT06329843 on ClinicalTrials.gov |
What this trial studies
This project aims to assess the accuracy of the Picterus Jaundice Pro smartphone application for measuring bilirubin levels in neonates, both preterm and term, during their first days of life. The study will compare these non-invasive measurements with traditional serum bilirubin levels, focusing on infants before and after phototherapy treatment. By using a proprietary calibration card placed on the infant's sternum, the study seeks to validate the effectiveness of this innovative approach in a real-world American population.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns, both preterm (≤ 35 weeks gestational age) and term (> 35 weeks gestational age), who do not have skin conditions that could affect measurement.
Not a fit: Patients with skin rashes, bruising, or other medical conditions that interfere with transcutaneous measurement will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and non-invasive monitoring of bilirubin levels in newborns, improving the management of neonatal jaundice.
How similar studies have performed: While this approach is innovative, similar studies using non-invasive bilirubin measurement techniques have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Salt Lake City, Utah
- Intermountain Health — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Timothy M Bahr, MS MD — Intermountain Health Care, Inc.
- Study coordinator: Timothy M Bahr, MS MD
- Email: Tim.Bahr@imail.org
- Phone: 801-602-6523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.