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

Neonatal Jaundice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05521607
• Other study ID #: IRB22-0480
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2023
• Est. completion date: June 15, 2025

Study information

• Verified date: March 2024
• Source: Picterus AS
• Contact: Jeanmarie Schied, MD
• Phone: 7737029200
• Email: jschied[@]peds.bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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%. The Picterus Calibration Card will be placed on the chest of the newborn with the hole in the card placed over the infant's sternum. A validated smartphone with Picterus JP will be used to collect digital images..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 15, 2025
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 14 Days

Eligibility

Inclusion Criteria:

• Infants born with gestational age > 37 weeks.
• Birth weight = 2500 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

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Neonatal
• Neonatal Jaundice

Intervention

Device:
• Picterus 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

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Picterus AS	University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.	Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.	3-6 months
Secondary	Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin.	Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin.	3-6months
Secondary	Correlate estimates of bilirubin levels obtained by Picterus JP with TSB, TcB and VA in newborns with high melanin content in the skin.	Correlate estimates of bilirubin levels obtained by Picterus JP with TSB, TcB and VA in newborns with high melanin content in the skin.	3-6 months
Secondary	Determine the accuracy of Picterus JP in newborns with high melanin content in the skin.	Determine the accuracy of Picterus JP in newborns with high melanin content in the skin.	3-6 months