Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05521607

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Neonatal Jaundice Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Jaundice, Neonatal 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

University of Chicago

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Jeanmarie Schied, MD

CONTACT

[email protected]

7737029200

About this study

A cross-sectional conductive study at the University of Chicago Medicine facilities (hospital and outreach clinics) will be conducted to include a total of 250 newborns with a desired distribution of skin color according to Neomar's scale : skin color 1 and 2: 20%, skin color 3: 30% and skin color 4: 50%. Skin color may also be quantitatively assessed using a handheld spectrophotometer (CM-700d, Konica Minolta).

The Picterus Calibration Card will be placed on the chest of the newborn with the hole in the card placed over the infant's chest. A validated smartphone with Picterus JP will be used to collect digital images, which are analysed to calculate a Picterus bilirubin value.

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 > 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

Treatment and study plan

Picterus Jaundice Pro (JP)

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 the blood of newborns, independent of skin color, using Picterus JP.

    Time frame: 3-6 months

    Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.

Secondary outcomes

  1. Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin.

    Time frame: 3-6months

    Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin.

  2. Correlate estimates of bilirubin levels obtained by Picterus JP with TSB, TcB and VA in newborns with high melanin content in the skin.

    Time frame: 3-6 months

    Correlate estimates of bilirubin levels obtained by Picterus JP with TSB, TcB and VA in newborns with high melanin content in the skin.

  3. Determine the accuracy of Picterus JP in newborns with high melanin content in the skin.

    Time frame: 3-6 months

    Determine the accuracy of Picterus JP in newborns with high melanin content in the skin.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeanmarie Schied, MD

CONTACT

[email protected]

7737029200

Sponsors and collaborators

Lead sponsor

Picterus AS

Industry

Collaborators

  • University of Chicago

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 30, 2022
Registry last updated
Sep 19, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.