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Search / Trial NCT05521607

Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago)

Launched by PICTERUS AS · Aug 26, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new smartphone-based tool called Picterus JP, designed to help doctors measure bilirubin levels in newborns with jaundice. Jaundice is a condition that causes yellowing of the skin and eyes in babies due to high bilirubin levels in their blood. The goal of this study is to find a way to accurately assess these levels regardless of the baby's skin color, making it easier and more reliable for healthcare providers to monitor and treat jaundice.

To take part in this trial, infants must be between 1 and 14 days old, born after 35 weeks of pregnancy, and weigh at least 1800 grams. They should also need a standard blood test for jaundice as part of their regular care. However, babies with certain medical conditions, skin issues, or those who have recently received treatment for jaundice are not eligible. Participants can expect to have their bilirubin levels assessed using the Picterus JP tool, which may offer a quick and non-invasive way to monitor their condition. This study is currently seeking participants at the University of Chicago Medicine and aims to improve how jaundice is diagnosed and managed in newborns.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Infants born with gestational age \> 35 weeks.
  • Birth weight ≥ 1800 grams
  • Age 1 - 14 days
  • Infants requiring a TSB blood sample for clinically suspected jaundice as part of standard care
  • Exclusion Criteria:
  • Infants showing signs of inborn disease.
  • Infants with skin rash or other skin disease that affects the skin where measurements are performed.
  • Infants transferred to the pediatric ward for medical treatment.
  • Infants that have received phototherapy in the last 24 hours

About Picterus As

Picterus AS is an innovative clinical trial sponsor dedicated to advancing medical research through the development of cutting-edge imaging technologies. Specializing in the integration of artificial intelligence and machine learning with diagnostic imaging, Picterus AS aims to enhance the accuracy and efficiency of clinical trials. By leveraging state-of-the-art methodologies and a commitment to patient-centered outcomes, the company seeks to optimize the drug development process and improve therapeutic interventions across various healthcare sectors. With a focus on collaboration and scientific rigor, Picterus AS is positioned to make significant contributions to the future of medical diagnostics and treatment efficacy.

Locations

Chicago, Illinois, United States

Chicago, Illinois, United States

Patients applied

0 patients applied

Trial Officials

Jeanmarie Schied, MD

Principal Investigator

University of Chicago

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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