Clinical Validation of the Screening Tool Picterus Jaundice Pro to Assess Neonatal Jaundice Using Different Types of Smartphones
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Picterus AS
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- jaundice screening
Study Overview
Brief Summary
The overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of Picterus JP on all smartphones.
Detailed Description
The overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of Picterus JP on all smartphones.
Picterus JP bilirubin estimates from a Samsung S7 will be compared with three smartphones with different camera types and a TcB measurement The clinical outcomes will be compared to our camera validation systems. Skin color measurements using a spectrophotometer will be used for technical optimization of the camera validation system
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 1 Day to 14 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Repeatable bilirubin measurement independent of phone
all subjects will receive bilirubin measurement from 4 different smartphones and a transcutaneous device to ensure that the measurement of bilirubin is not affected by phone camera
Intervention: Picterus JP (Device)
Outcomes
Primary Outcomes
jaundice screening
Time Frame: 6 months
reproducible jaundice screening independent of smartphone used
Secondary Outcomes
No secondary outcomes reported