Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones (allphones)

Picterus

Status: Enrolling

Conditions: Neonatal Jaundice

Treatments: Device: Picterus JP

Study type: Interventional

Funder types: Industry

Identifiers

NCT05955144

allphone

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 14 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Repeatable bilirubin measurement independent of phone

Other group

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

Treatment:

Device: Picterus JP