RecruitingNot ApplicableNCT05521607

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

Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice in Newborns with High Melanin Content (Chicago)


Sponsor

Picterus AS

Enrollment

250 participants

Start Date

Jan 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

A cross-sectional conductive study at the University of Chicago Medicine facilities (hospital and outreach clinics) to enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.


Eligibility

Min Age: 1 DayMax Age: 14 Days

Inclusion Criteria4

  • 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 Criteria4

  • 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

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Interventions

DEVICEPicterus Jaundice Pro (JP)

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


Locations(1)

University of Chicago

Chicago, Illinois, United States

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NCT05521607


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