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Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05955144
Acronym
allphones
Enrollment
100
Registered
2023-07-21
Start date
2022-10-01
Completion date
2024-12-01
Last updated
2023-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Jaundice

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

Interventions

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

Sponsors

Picterus AS
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 14 Days
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

Design outcomes

Primary

MeasureTime frameDescription
jaundice screening6 monthsreproducible jaundice screening independent of smartphone used

Countries

Norway

Contacts

Primary ContactDeborah Hill
deborah@picterus.com45188628

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026