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

Primary Purpose

Jaundice, Neonatal

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Picterus Jaundice Pro
Sponsored by
Picterus AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Jaundice, Neonatal

Eligibility Criteria

1 Day - 14 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Södersjukhuset

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

Enable high qualitative estimation of bilirubin levels in newborns, independent of skin color, using Picterus JP
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)

Secondary Outcome Measures

Comparison of Picterus-generated estimate with TsB
Compare bilirubin estimates calculated with the adjusted algoritm from the images with TSB measurements
Comparison of Picterus-generated estimate with TcB
Compare bilirubin estimates calculated with the adjusted algoritm from the images with TcB measurements
Comparison of Picterus-generated estimate with visual assessment.
Compare bilirubin estimates calculated with the adjusted algoritm from the images with visual assessment.

Full Information

First Posted
December 6, 2022
Last Updated
March 27, 2023
Sponsor
Picterus AS
Collaborators
Stockholm South General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05650463
Brief Title
Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns
Official Title
Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
November 29, 2021 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Picterus AS
Collaborators
Stockholm South General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaundice, Neonatal

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enable high qualitative estimation of bilirubin levels in the blood of new-borns
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Picterus Jaundice Pro
Intervention Description
Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.
Primary Outcome Measure Information:
Title
Enable high qualitative estimation of bilirubin levels in newborns, independent of skin color, using Picterus JP
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Comparison of Picterus-generated estimate with TsB
Description
Compare bilirubin estimates calculated with the adjusted algoritm from the images with TSB measurements
Time Frame
1-2 hours
Title
Comparison of Picterus-generated estimate with TcB
Description
Compare bilirubin estimates calculated with the adjusted algoritm from the images with TcB measurements
Time Frame
5-10min
Title
Comparison of Picterus-generated estimate with visual assessment.
Description
Compare bilirubin estimates calculated with the adjusted algoritm from the images with visual assessment.
Time Frame
5-10min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lobke Gierman, PhD
Organizational Affiliation
Picterus AS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Södersjukhuset
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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