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

Sponsor
Picterus AS (Industry)
Overall Status
Completed
CT.gov ID
NCT05650463
Collaborator
Stockholm South General Hospital (Other)
150
Enrollment
1
Location
1
Arm
9
Actual Duration (Months)
16.6
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: Picterus Jaundice Pro
 N/A

Detailed Description

To adjust Picterus JP to work in newborns with more pigmented skin, we 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 Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns
Actual Study Start Date :
Nov 29, 2021
Actual Primary Completion Date :
Nov 29, 2021
Actual Study Completion Date :
Aug 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Enable high qualitative estimation of bilirubin levels in newborns, independent of skin color, using Picterus JP [6 months]

    Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with Neomar scale type 4

Secondary Outcome Measures

  1. Comparison of Picterus-generated estimate with TsB [1-2 hours]

    Compare bilirubin estimates calculated with the adjusted algoritm from the images with TSB measurements

  2. Comparison of Picterus-generated estimate with TcB [5-10min]

    Compare bilirubin estimates calculated with the adjusted algoritm from the images with TcB measurements

  3. Comparison of Picterus-generated estimate with visual assessment. [5-10min]

    Compare bilirubin estimates calculated with the adjusted algoritm from the images with visual assessment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 14 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Södersjukhuset Stockholm Sweden 11883

Sponsors and Collaborators

  • Picterus AS
  • Stockholm South General Hospital

Investigators

  • Principal Investigator: Lobke Gierman, PhD, Picterus AS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Picterus AS
ClinicalTrials.gov Identifier:
NCT05650463
Other Study ID Numbers:
  • Stockholm
First Posted:
Dec 14, 2022
Last Update Posted:
Dec 14, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Jaundice, Neonatal
Jaundice

Study Results

No Results Posted as of Dec 14, 2022