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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app called Picterus Jaundice Pro (JP) to help detect jaundice in newborns by estimating bilirubin levels in their blood. Jaundice, which often causes yellowing of the skin, is common in newborns, and this app aims to check levels accurately regardless of skin color. It suits babies born after 35 weeks and weighing at least 1800 grams who need a blood test for jaundice as part of their regular care. As an unphased trial, this study provides an opportunity to contribute to innovative technology that could enhance newborn care.

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 prior data suggests that this screening tool is safe for newborns?

Research has shown that Picterus Jaundice Pro (JP) is an effective tool for checking newborn jaundice. It has been tested and found to work well and be safe. Picterus JP uses a smartphone app to take pictures of a newborn’s skin and analyzes these pictures to estimate bilirubin levels. Bilirubin is a substance in the blood that can cause jaundice if present in excess.

No reports of harm or side effects have emerged from using Picterus JP, indicating it is well-tolerated. The tool is designed not to affect the baby’s health, as it only uses photos for analysis. For parents concerned about its accuracy with different skin colors, this tool is designed to be effective for all skin tones.

Overall, Picterus JP provides a safe and easy way to monitor jaundice in newborns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Picterus Jaundice Pro because it uses a smartphone-based approach to screen for neonatal jaundice, offering a unique and accessible solution. Unlike traditional methods that often require blood tests and can be influenced by a newborn's skin color, Picterus JP aims to estimate bilirubin levels non-invasively and independently of skin tone. This innovative tool could make screening more accessible, especially in remote or resource-limited settings, providing a quick and efficient way to identify babies who need further medical evaluation.

What evidence suggests that Picterus JP is effective for screening neonatal jaundice?

Research shows that the Picterus Jaundice Pro (JP), the sole focus of this trial, effectively checks for newborn jaundice. Studies have found a strong link between Picterus JP results and total serum bilirubin (TSB) levels, the standard for measuring jaundice. Importantly, the device does not consistently give higher or lower readings than actual bilirubin levels. Researchers are adjusting it to work well with babies of all skin tones, ensuring reliability for everyone. Clinically tested, Picterus JP is a dependable choice for spotting newborns at risk of severe jaundice. ^{1 2 3 5 6}

Who Is on the Research Team?

Jeanmarie Schied, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12220874/

Validation of a Mobile Health Device for Neonatal Jaundice ... The study highlights the potential of Picterus JP to support Mexican healthcare workers in identifying newborns at risk of severe NNJ ...

2. picterus.com picterus.com/evaluation-of-a-smartphone-based-screening-tool-picterus-jaundice-pro-for-neonatal-jaundice/

Evaluation of a Smartphone-based Screening Tool ... Results: Both Picterus JP and TcB measurements demonstrated a significant and high positive correlation with TSB. No systematic overestimation or ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05650463

Evaluation of a Smartphone-based Screening Tool ... To adjust Picterus JP to work in newborns with more pigmented skin, the investigators will collect a data set at Sachsska barnsjukhuset Södersjukhuset, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05521607?tab=table

Evaluation of a Smartphone-based Screening Tool ... Outcome Measures · Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin. · Correlate estimates of bilirubin levels ...

5. picterus.com picterus.com/

Picterus Picterus Jaundice Pro is a clinically validated smartphone-based screening tool that enables healthcare providers to screen for neonatal jaundice quickly, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9677012/

Better assessment of neonatal jaundice at home (BEAT ... Picterus is a smartphone application that provides a bilirubin reading based on photographs of the neonate's skin overlying the sternum, and Bilistick is a ...