← Back to Search

Device

Smartphone-based Screening Tool for Neonatal Jaundice

N/A
Recruiting
Led By Jeanmarie Schied, MD
Research Sponsored by Picterus AS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 1 - 14 days
Infants born with gestational age > 37 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6months
Awards & highlights

Study Summary

This trial will help determine how well a new tool can accurately measure bilirubin levels in newborns' blood, regardless of skin color.

Who is the study for?
This trial is for newborns who are between 1-14 days old, born at or after 37 weeks of pregnancy, and weigh at least 2500 grams. They must need a blood test for suspected jaundice as part of their usual care. Babies with skin conditions where the device is used, those needing hospital treatment beyond initial care, recently treated with phototherapy, or showing signs of congenital disease cannot participate.Check my eligibility
What is being tested?
The study tests Picterus Jaundice Pro (JP), a smartphone-based tool designed to estimate bilirubin levels in newborns' blood accurately across different skin tones without drawing blood.See study design
What are the potential side effects?
Since the intervention involves non-invasive screening using a smartphone application, there are no direct side effects associated with its use like those seen with medications or invasive procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a newborn, between 1 to 14 days old.
Select...
My baby was born full-term.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-6months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
Secondary outcome measures
Adapt the current algorithm of Picterus JP to 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.
Determine the accuracy of Picterus JP in newborns with high melanin content in the skin.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Enable high qualitative estimation of bilirubin levels in the blood of new-bornsExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of ChicagoOTHER
1,012 Previous Clinical Trials
733,820 Total Patients Enrolled
Picterus ASLead Sponsor
13 Previous Clinical Trials
2,679 Total Patients Enrolled
Jeanmarie Schied, MDPrincipal InvestigatorUniversity of Chicago

Media Library

Picterus Jaundice Pro (JP) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05521607 — N/A
Neonatal Jaundice Research Study Groups: Enable high qualitative estimation of bilirubin levels in the blood of new-borns
Neonatal Jaundice Clinical Trial 2023: Picterus Jaundice Pro (JP) Highlights & Side Effects. Trial Name: NCT05521607 — N/A
Picterus Jaundice Pro (JP) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05521607 — N/A
~0 spots leftby Jun 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top