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Completed

NCT Number: NCT05650463

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

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

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Key information

Conditions

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

Age range

1 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Södersjukhuset

Stockholm, 11883, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Comparison of Picterus-generated estimate with TsB

    Time frame: 1-2 hours

    Compare bilirubin estimates calculated with the adjusted algoritm from the images with TSB measurements

  2. Comparison of Picterus-generated estimate with TcB

    Time frame: 5-10min

    Compare bilirubin estimates calculated with the adjusted algoritm from the images with TcB measurements

  3. Comparison of Picterus-generated estimate with visual assessment.

    Time frame: 5-10min

    Compare bilirubin estimates calculated with the adjusted algoritm from the images with visual assessment.

Sponsors and collaborators

Lead sponsor

Picterus AS

Industry

Collaborators

  • Stockholm South General Hospital

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 14, 2022
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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