Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns

NCT ID: NCT05650463

Last Updated: 2023-03-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-29

Study Completion Date

2022-08-31

Brief Summary

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A cross-sectional study at the Södersjukehuset facility (Stockholm, Sweden) collect data of newborns from a population with Neomar scale type 4 to adjust the algorithm of Picterus JP

Detailed Description

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To adjust Picterus JP to work in newborns with more pigmented skin, the investigators will collect a data set at Sachsska barnsjukhuset Södersjukhuset, Stockholm Sweden from 150 newborns with dark skins using Picterus JP, TcB, skin measurements from a spectrometer, visual assessment, and total serum bilirubin (TSB) levels. As a control, newborns with Neomar scale 1-3 will be included.

Conditions

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Jaundice, Neonatal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Enable high qualitative estimation of bilirubin levels in the blood of new-borns

There is only one arm in this study which is to enable high qualitative estimation of bilirubin levels in the blood of new-borns with darker skin types using Picterus JP.

Group Type EXPERIMENTAL

Picterus Jaundice Pro

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 place.

Interventions

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Picterus Jaundice Pro

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Infants born with gestational age ≥ 37
* Birth weight ≥ 2500g
* Age 1 - 14 days
* Will have a blood sample performed, either for clinically suspected jaundice or newborn screening sample

Exclusion Criteria

* Infants showing signs of inborn disease
* Infants transferred to pediatric ward for treatment
* Infants that have received phototherapy
Minimum Eligible Age

1 Day

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stockholm South General Hospital

OTHER

Sponsor Role collaborator

Picterus AS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lobke Gierman, PhD

Role: PRINCIPAL_INVESTIGATOR

Picterus AS

Locations

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Södersjukhuset

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Stockholm

Identifier Type: -

Identifier Source: org_study_id

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