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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 belowSelect...
I am a newborn, between 1 to 14 days old.
Select...
My baby was born full-term.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-6months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6months
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
1,004 Previous Clinical Trials
819,527 Total Patients Enrolled
Picterus ASLead Sponsor
12 Previous Clinical Trials
2,529 Total Patients Enrolled
Jeanmarie Schied, MDPrincipal InvestigatorUniversity of Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My infant has a skin rash or disease affecting where measurements are taken.My baby was born full-term.I am a newborn, between 1 to 14 days old.You weighed at least 2500 grams (about 5.5 pounds) when you were born.Babies who need a blood test for suspected jaundice as part of regular medical care.My infant is currently in the pediatric ward for treatment.My infant received phototherapy in the last day.My infant shows signs of a genetic disease.
Research Study Groups:
This trial has the following groups:- Group 1: Enable high qualitative estimation of bilirubin levels in the blood of new-borns
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings for participants in this research project?
"Indeed, the clinicaltrials.gov database illustrates that this medical trial is recruiting participants - it was first posted on November 14th 2022 and updated lastly on November 1st 2022. This study requires 250 individuals from a single site to participate."
Answered by AI
What is the current cohort size for this research trial?
"Affirmative. Clinicaltrials.gov reveals that this medical trial is currently enrolling subjects, the initial posting of which was on November 14th 2022 and updated on the 1st of November 2022. The research seeks to recruit 250 individuals from a single centre."
Answered by AI
Are seniors a viable demographic for this experiment?
"The parameters of acceptance for this trial necessitate that applicants must be from 1 Day old to 14 Days. Moreover, there are 8 trials actively recruiting minors and a single one enlisting elderly patients."
Answered by AI
Who can qualify to participate in this experimental research?
"Should individuals have been inflicted with jaundice, neonatal and are between 1 day old to 14 days of age, they may be suitable for this study which is currently admitting approximately 250 participants."
Answered by AI
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