Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Picterus Jaundice Pro (JP).
- Who it may be relevant to
- Registry conditions: Neonatal Jaundice. Basic parameters: 1 Day — 14 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice in Newborns with High Melanin Content (Chicago)
Overview
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%. 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.
Interventions
- Device Picterus Jaundice Pro (JP)
Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.
Primary outcome measures
- Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP. [Time frame: 3-6 months]
Secondary outcome measures (3)
- Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin. [Time frame: 3-6months]
- 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 months]
- Determine the accuracy of Picterus JP in newborns with high melanin content in the skin. [Time frame: 3-6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- University of Chicago — Chicago
Identifiers
NCT: NCT05521607 · IRB22-0480