Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones

NCT ID: NCT05955144

Last Updated: 2023-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-12-01

Brief Summary

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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

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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

Conditions

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Neonatal Jaundice

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Repeatable bilirubin measurement independent of phone

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

Group Type OTHER

Picterus JP

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Picterus AS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St Olav Hospital

Trondheim, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Deborah Hill

Role: CONTACT

Facility Contacts

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Ragnhild Støen

Role: primary

Other Identifiers

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allphone

Identifier Type: -

Identifier Source: org_study_id

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