ClinicalTrials.gg
Sign In
RecruitingNCT05521607Updated Sep 19, 2024

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

An interventional study of Picterus Jaundice Pro (JP) in Neonatal Jaundice, sponsored by Picterus AS. Recruiting at 1 site in United States. Open to participants aged 1 Day to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Picterus AS · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
1 Day to 14 Days
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Neonatal Jaundice

Browse trials for

03

In context

Jaundice, Neonatal

110 studies on the registry are indexed under Jaundice, Neonatal; 28 are open to participants now.

This study's planned enrollment of 250 is above the median of 150 across 78 interventional studies indexed under Jaundice, Neonatal.

Browse Jaundice, Neonatal studies →

Lead sponsor

Picterus AS is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 14 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

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

    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.

    Device: Picterus Jaundice Pro (JP)

Interventions

  • DevicePicterus 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.

06

What researchers measure

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 months

Secondary 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: 3-6months

  2. 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 months

  3. 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 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2023 (actual). Primary completion is estimated for Oct 2024, 21 months after the start.

Of 45 interventional studies with no phase under Jaundice, Neonatal, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's planned 21 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2022
First posted
Aug 30, 2022
StartActual
Jan 6, 2023
Primary completionEst.
Oct 31, 2024
CompletionEst.
Jun 15, 2025
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05521607
Lead sponsor
Picterus AS
Collaborators
University of Chicago
Responsible party
Sponsor
First posted
Aug 30, 2022
Start date
Jan 6, 2023
Primary completion
Oct 31, 2024 (estimated)
Completion
Jun 15, 2025 (estimated)
Last update
Sep 19, 2024

Study contacts

Jeanmarie Schied, MD
Contact
jschied@peds.bsd.uchicago.edu
7737029200
Jeanmarie Schied, MD
principal investigator · University of Chicago

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Jaundice, Neonatal →

Other studies from this sponsor

Picterus AS

Start the discussion