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

Not Applicable

Completed

• Conditions: Jaundice, Neonatal
• Interventions: Device: Picterus Jaundice Pro

• Registration Number: NCT05650463
• Lead Sponsor: Picterus AS

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.

Study Timeline

• Study Start: 2021-11-29
• Primary Completion: 2021-11-29
• Study Completion: 2022-08-31
• Status Verified: 2022-12
• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-14
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enable high qualitative estimation of bilirubin levels in the blood of new-borns	Picterus Jaundice Pro	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.

Primary Outcome Measures

Name	Time	Method
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 neonatal skin color scale type 4 (with type 1 being lower-melanin level and Type 4 being higher-melanin level)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Södersjukhuset; 🇸🇪 Stockholm, Sweden