Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago)
ConditionNeonatal Jaundice
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-14
SponsorPicterus AS
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Single group
Treatments tested in this trial
Picterus Jaundice Pro (JP)
DeviceUse Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Enable high qualitative estimation of bilirubin levels in the blood of new-bornsOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3-6 monthsSecondary outcomes
1
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.
Time frame
3-6months2
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.
Time frame
3-6 months3
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.
Time frame
3-6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Picterus AS
Lead sponsor
University of Chicago
Collaborator
Source ClinicalTrials.gov