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NCT05955144 Clinical Trial

Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones

Neonatal Jaundice Clinical Trial

— allphones  

Official title:
Clinical Validation of the Screening Tool Picterus Jaundice Pro to Assess Neonatal Jaundice Using Different Types of Smartphones

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05955144
Other study ID # allphone
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date December 1, 2024

Study information
Verified date July 2023
Source Picterus AS
Contact Deborah Hill
Phone 45188628
Email deborah@picterus.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 1, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Day to 14 Days
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Picterus JP
Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is placed.

Locations
Country Name City State
Norway St Olav Hospital Trondheim

Sponsors (1)
Lead Sponsor Collaborator
Picterus AS

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary jaundice screening reproducible jaundice screening independent of smartphone used 6 months
See also
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