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NCT05650463 Clinical Trial

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

Jaundice, Neonatal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05650463
Other study ID # Stockholm
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 29, 2021
Est. completion date August 31, 2022

Study information
Verified date December 2022
Source Picterus AS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date August 31, 2022
Est. primary completion date November 29, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Day to 14 Days
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Sweden Södersjukhuset Stockholm

Sponsors (2)
Lead Sponsor Collaborator
Picterus AS Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) 6 months
Secondary Comparison of Picterus-generated estimate with TsB Compare bilirubin estimates calculated with the adjusted algoritm from the images with TSB measurements 1-2 hours
Secondary Comparison of Picterus-generated estimate with TcB Compare bilirubin estimates calculated with the adjusted algoritm from the images with TcB measurements 5-10min
Secondary Comparison of Picterus-generated estimate with visual assessment. Compare bilirubin estimates calculated with the adjusted algoritm from the images with visual assessment. 5-10min
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