Smartphone-based Screening Tool for Neonatal Jaundice

Overseen By Jeanmarie Schied, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Picterus AS

Disqualifiers: Inborn disease, Skin disease, Phototherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

250 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Picterus Jaundice Pro for neonatal jaundice?

Research shows that smartphone-based tools, like Picterus, can effectively estimate bilirubin levels in newborns by analyzing skin images, which correlates well with traditional blood tests. This suggests that Picterus Jaundice Pro could be a reliable method for screening neonatal jaundice. ^{1 2 3 4 5}

How is the Picterus Jaundice Pro treatment different from other treatments for neonatal jaundice?

Picterus Jaundice Pro is unique because it uses a smartphone app to screen for neonatal jaundice by analyzing the color of the sclera (the white part of the eye), which avoids issues with skin color and lighting. This method is low-cost, easy to use at home, and doesn't require additional equipment, making it accessible for widespread use, especially in low-resource settings. ^{1 2 3 6 7}

Research Team

Jeanmarie Schied, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

My infant has a skin rash or disease affecting where measurements are taken.

My infant is currently in the pediatric ward for treatment.

My infant received phototherapy in the last day.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Data Collection

Digital images are collected using a smartphone with Picterus JP to estimate bilirubin levels in newborns

3-6 months

Multiple visits (in-person)

Follow-up

Participants are monitored for the accuracy and adaptation of the Picterus JP tool

3-6 months

Treatment Details

Interventions

• Picterus Jaundice Pro (JP)

Trial Overview 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.

Participant Groups

Group I: Enable high qualitative estimation of bilirubin levels in the blood of new-borns Experimental Treatment 1 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.

Picterus Jaundice Pro (JP) is already approved in European Union, United States for the following indications:

Approved in European Union as Picterus Jaundice Pro for:

• Neonatal jaundice screening

Approved in United States as Picterus Jaundice Pro for:

• Neonatal jaundice screening

Who Is Running the Clinical Trial?

Picterus AS

Lead Sponsor

Trials

14

Recruited

3,200+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Findings from Research

The smartphone-based screening application Biliscan demonstrated moderate correlation with traditional bilirubin measurement methods, showing a sensitivity of 76.92% and specificity of 70.83% for detecting jaundice that requires treatment.

Despite its potential, the study found that Biliscan's agreement with standard serum bilirubin levels was only mediocre, indicating that further improvements to the app and larger studies are needed before it can be reliably used for neonatal jaundice screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a smartphone-based screening tool (Biliscan) for neonatal jaundice in a multi-ethnic neonatal population. Ngeow, AJH., Tan, MG., Dong, X., et al.[2023]

This study will evaluate the effectiveness of universal transcutaneous bilirubin (TcB) screening in detecting severe neonatal hyperbilirubinaemia compared to traditional visual inspection, aiming to improve early diagnosis and reduce the need for painful heel pricks for bilirubin quantification.

The multicenter study will include 2310 neonates over two years, assessing the impact of TcB and a smartphone app on treatment necessity and heel prick frequency, with ethical approval and informed consent from parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better assessment of neonatal jaundice at home (BEAT Jaundice @home): protocol for a prospective, multicentre diagnostic study. Westenberg, LEH., van der Geest, BAM., Lingsma, HF., et al.[2022]

The neoSCB smartphone application demonstrated high sensitivity (0.94) and specificity (0.73) for screening neonatal jaundice, making it a reliable tool for identifying infants with elevated bilirubin levels.

With a total of 724 infants studied, the neoSCB's performance was comparable to the established JM-105 device, suggesting it could serve as an affordable and effective screening option in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validating a Sclera-Based Smartphone Application for Screening Jaundiced Newborns in Ghana. Enweronu-Laryea, C., Leung, T., Outlaw, F., et al.[2022]

A novel smartphone-based method for estimating bilirubin levels from color-calibrated images showed a strong correlation with serum bilirubin levels (Pearson's r = 0.84) in a study of 302 newborns, indicating its potential effectiveness in screening for neonatal jaundice.

The tool demonstrated a sensitivity of 100% and a specificity of 69% for identifying severe jaundice, suggesting it could be a reliable screening option for early detection of this condition in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilirubin estimates from smartphone images of newborn infants' skin correlated highly to serum bilirubin levels. Aune, A., Vartdal, G., Bergseng, H., et al.[2021]

The automated image-based bilirubin (AIB) testing technique showed no significant difference in bilirubin levels compared to traditional peripheral blood tests, indicating its accuracy for assessing jaundice in neonates.

With a sensitivity of 82% and specificity of 60%, AIB can effectively monitor bilirubin levels, making it a promising tool for the objective follow-up of jaundice in term and late preterm neonates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of an automatic image-based screening technique for neonatal hyperbilirubinemia]. Rong, ZH., Luo, F., Ma, LY., et al.[2018]

A novel smartphone method for screening neonatal jaundice by imaging the sclera shows promising results, achieving a strong correlation (r = 0.75) with traditional blood tests for bilirubin levels in a pilot study of 37 neonates.

The method demonstrated high sensitivity (100%) for identifying severe jaundice (TSB > 250μmol/L) and comparable performance to existing transcutaneous bilirubinometers, suggesting it could be a practical tool for early jaundice detection in various settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone screening for neonatal jaundice via ambient-subtracted sclera chromaticity. Outlaw, F., Nixon, M., Odeyemi, O., et al.[2023]

The JM 103 device is an effective screening tool for neonatal jaundice, showing a strong correlation between transcutaneous bilirubin (TcB) and serum bilirubin (TSB) measurements across 451 newborns of varying skin colors.

While the JM 103 generally performs well, it tends to underestimate TSB in infants with light and medium skin tones and overestimate it in those with dark skin, indicating that skin color may influence its accuracy, although no significant clinical differences were found.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of skin colour on diagnostic accuracy of the jaundice meter JM 103 in newborns. Samiee-Zafarghandy, S., Feberova, J., Williams, K., et al.[2019]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Validation of a smartphone-based screening tool (Biliscan) for neonatal jaundice in a multi-ethnic neonatal population. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Better assessment of neonatal jaundice at home (BEAT Jaundice @home): protocol for a prospective, multicentre diagnostic study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Validating a Sclera-Based Smartphone Application for Screening Jaundiced Newborns in Ghana. [2022]

4. Norway pubmed.ncbi.nlm.nih.gov

Bilirubin estimates from smartphone images of newborn infants' skin correlated highly to serum bilirubin levels. [2021]

5. China pubmed.ncbi.nlm.nih.gov

[Evaluation of an automatic image-based screening technique for neonatal hyperbilirubinemia]. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Smartphone screening for neonatal jaundice via ambient-subtracted sclera chromaticity. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Influence of skin colour on diagnostic accuracy of the jaundice meter JM 103 in newborns. [2019]