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

March 27, 2023 updated by: Picterus AS
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 11883
        • Sodersjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enable high qualitative estimation of bilirubin levels in newborns, independent of skin color, using Picterus JP
Time Frame: 6 months
Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with Neomar neonatal skin color scale type 4 (with type 1 being lower-melanin level and Type 4 being higher-melanin level)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Picterus-generated estimate with TsB
Time Frame: 1-2 hours
Compare bilirubin estimates calculated with the adjusted algoritm from the images with TSB measurements
1-2 hours
Comparison of Picterus-generated estimate with TcB
Time Frame: 5-10min
Compare bilirubin estimates calculated with the adjusted algoritm from the images with TcB measurements
5-10min
Comparison of Picterus-generated estimate with visual assessment.
Time Frame: 5-10min
Compare bilirubin estimates calculated with the adjusted algoritm from the images with visual assessment.
5-10min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Picterus AS

Collaborators

Stockholm South General Hospital

Investigators

  • Principal Investigator: Lobke Gierman, PhD, Picterus AS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2021

Primary Completion (Actual)

November 29, 2021

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stockholm

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Jaundice, Neonatal

Clinical Trials on Picterus Jaundice Pro

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe