Validation of a smartphone tool for measuring neonatal jaundice
Clinical Validation of the Screening Tool Picterus Jaundice Pro to Assess Neonatal Jaundice Using Different Types of Smartphones
This study is testing a smartphone tool to see if it can accurately measure jaundice in newborns by comparing readings from different phone cameras.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 1 Day to 14 Days |
| Sex | All |
| Sponsor | Picterus AS Industry-sponsored |
| Locations | 1 site (Trondheim) |
| Trial ID | NCT05955144 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the Picterus JP screening tool for measuring bilirubin levels in infants using various smartphone cameras. It will compare bilirubin estimates from a Samsung S7 with those from three other smartphones and a transcutaneous bilirubin (TcB) measurement. The study will also utilize skin color measurements to optimize the camera validation system for accurate readings across different devices. The goal is to ensure that the Picterus JP tool can be reliably used on any smartphone.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born after 37 weeks of gestation, weighing at least 2500 grams, and aged between 1 to 14 days.
Not a fit: Patients who may not benefit include those with inborn diseases, skin conditions affecting measurement areas, or those who have recently undergone phototherapy.
Why it matters
Potential benefit: If successful, this tool could provide a convenient and accessible method for monitoring neonatal jaundice in infants.
How similar studies have performed: While the approach of using smartphone technology for medical measurements is gaining traction, this specific validation of the Picterus JP tool is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants born with gestational age \> 37 weeks. * Birth weight ≥ 2500 grams * Age 1 - 14 days 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
Trondheim
- St Olav Hospital — Trondheim, Norway (Recruiting)
Study contacts
- Study coordinator: Deborah Hill
- Email: deborah@picterus.com
- Phone: 45188628
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.