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

NCT05650463 | Completed

• 1 other identifier: Stockholm
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Jaundice, Neonatal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Comparison of Picterus-generated estimate with TsB

  1-2 hours

• Comparison of Picterus-generated estimate with TcB

  5-10min

• Comparison of Picterus-generated estimate with visual assessment.

  5-10min

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Picterus Jaundice Pro DEVICE

Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.

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

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Infants showing signs of inborn disease
• Infants transferred to pediatric ward for treatment
• Infants that have received phototherapy

Sponsors & Collaborators

• Picterus AS: lead
• Stockholm South General Hospital: collaborator

Study Sites (1)

Södersjukhuset

Stockholm, 11883, Sweden

Location

MeSH Terms

Conditions

Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lobke Gierman, PhD

  Picterus AS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: November 29, 2021
• Primary Completion: November 29, 2021
• Study Completion: August 31, 2022
• Last Updated: March 29, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)