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

Not Applicable

Recruiting

• Conditions: Neonatal Jaundice
• Interventions: Device: Picterus Jaundice Pro (JP)

• Registration Number: NCT05521607
• Lead Sponsor: Picterus AS

Brief 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.

Detailed 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..

Study Timeline

• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-30
• Study Start: 2023-01-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-06-15
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enable high qualitative estimation of bilirubin levels in the blood of new-borns	Picterus Jaundice Pro (JP)	There is only one arm in this study which is to enable high qualitative estimation of bilirubin levels in the blood of new-borns, independent of skin color, using Picterus JP.

Primary Outcome Measures

Name	Time	Method
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.	3-6 months	Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.

Secondary Outcome Measures

Name	Time	Method
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	Correlate estimates of bilirubin levels obtained by Picterus JP with TSB, TcB and VA 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	Determine the accuracy of Picterus JP in 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	Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States