Smartphone tool for measuring jaundice in newborns
Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice in Newborns with High Melanin Content (Chicago)
This study is testing a smartphone tool to see if it can accurately measure jaundice levels in newborns, helping doctors better manage the condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 1 Day to 14 Days |
| Sex | All |
| Sponsor | Picterus AS Industry-sponsored |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05521607 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a smartphone-based screening tool called Picterus JP for estimating bilirubin levels in newborns with jaundice. Conducted at the University of Chicago Medicine, it aims to include 250 newborns of varying skin colors to ensure accurate readings regardless of pigmentation. The process involves placing a calibration card on the infant's chest and using a smartphone to capture images, which are then analyzed to determine bilirubin levels. The study seeks to improve jaundice detection and management in newborns.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born after 35 weeks of gestation, weighing at least 1800 grams, and aged between 1 to 14 days who require a blood sample for suspected jaundice.
Not a fit: Patients who may not benefit include those with inborn diseases, skin conditions affecting measurement sites, or those who have recently undergone phototherapy.
Why it matters
Potential benefit: If successful, this tool could provide a non-invasive and accurate method for monitoring jaundice in newborns, leading to better clinical outcomes.
How similar studies have performed: Other studies have shown promise in using smartphone technology for medical diagnostics, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants born with gestational age \> 35 weeks. * Birth weight ≥ 1800 grams * Age 1 - 14 days * Infants requiring a TSB blood sample for clinically suspected jaundice as part of standard care Exclusion Criteria: * Infants showing signs of inborn disease. * Infants with skin rash or other skin disease that affects the skin where measurements are performed. * Infants transferred to the pediatric ward for medical treatment. * Infants that have received phototherapy in the last 24 hours
Where this trial is running
Chicago, Illinois
- University of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Jeanmarie Schied, MD — University of Chicago
- Study coordinator: Jeanmarie Schied, MD
- Email: jschied@peds.bsd.uchicago.edu
- Phone: 7737029200
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.