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

Picterus AS1 site in 1 country150 target enrollmentNovember 29, 2021

ConditionsJaundice, Neonatal

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Jaundice, Neonatal
Sponsor: Picterus AS
Enrollment: 150
Locations: 1
Primary Endpoint: Enable high qualitative estimation of bilirubin levels in newborns, independent of skin color, using Picterus JP
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 29, 2021

End Date

August 31, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Picterus AS

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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)