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

Picterus

Status: Completed

Conditions: Jaundice, Neonatal

Treatments: Device: Picterus Jaundice Pro

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05650463

Stockholm

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 1 to 14 days old

Volunteers: Accepts 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

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

Experimental group

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.

Treatment:

Device: Picterus Jaundice Pro