Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones

Not Applicable

Recruiting

• Conditions: Neonatal Jaundice
• Interventions: Device: Picterus JP

• Registration Number: NCT05955144
• Lead Sponsor: Picterus AS

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 Timeline

• Study Start: 2022-10-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-13
• Last Update Submitted: 2023-07-13
• Study First Posted: 2023-07-21
• Last Update Posted: 2023-07-21
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Repeatable bilirubin measurement independent of phone	Picterus JP	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

Primary Outcome Measures

Name	Time	Method
jaundice screening	6 months	reproducible jaundice screening independent of smartphone used

Trial Locations

Locations (1)

St Olav Hospital; 🇳🇴 Trondheim, Norway