Back to resultsClinical Validation of the Screening Tool Picterus JP Using Different Smartphones (allphones)
Primary Purpose
Neonatal Jaundice
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Picterus JP
Sponsored by
About this trial
This is an interventional diagnostic trial for Neonatal Jaundice
Eligibility 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
Sites / Locations
- St Olav HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Repeatable bilirubin measurement independent of phone
Arm Description
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
Outcomes
Primary Outcome Measures
jaundice screening
reproducible jaundice screening independent of smartphone used
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05955144
Brief Title
Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones
Acronym
allphones
Official Title
Clinical Validation of the Screening Tool Picterus Jaundice Pro to Assess Neonatal Jaundice Using Different Types of Smartphones
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Picterus AS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Jaundice
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Repeatable bilirubin measurement independent of phone
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
Picterus JP
Intervention Description
Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is placed.
Primary Outcome Measure Information:
Title
jaundice screening
Description
reproducible jaundice screening independent of smartphone used
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Hill
Phone
45188628
Email
deborah@picterus.com
Facility Information:
Facility Name
St Olav Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ragnhild Støen
Phone
95034601
Email
ragnhild.stoen@ntnu.no
12. IPD Sharing Statement
Learn more about this trial
Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones
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