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

Picterus

Status: Enrolling

Conditions: Neonatal Jaundice

Treatments: Device: Picterus Jaundice Pro (JP)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05521607

IRB22-0480

Details and patient eligibility

About

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.

Full 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%. 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 1 to 14 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Enable high qualitative estimation of bilirubin levels in the blood of new-borns

Other group

Description:

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.

Treatment:

Device: Picterus Jaundice Pro (JP)