Jaundice, NeonatalNCT06276582
Screening for Neonatal Jaundice With a Mobile Health Device: a Validation Study in Oaxaca, Mexico.
A study testing Screening for neonatal jaundice with a mobile health device in people with Jaundice, Neonatal, run by Norwegian University of Science and Technology at 1 site in Mexico.
Trial summary
The performance and accuracy of the smartphone application (app) Picterus Jaundice Pro (PicterusJP) will be validated by a cross-sectional study conducted in low resource settings in Mexico. Read more about this study
- Who is it for?
- Ages 1 day to 14 days
- Conditions the study is for
- Jaundice, Neonatal
- What is being tested?
- Screening for neonatal jaundice with a mobile health device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteMexico
- Study dates
- 17 Jan 2023to 8 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age of 37 weeks or more
- birth weight of 2500 g and above
- newborns in whom a blood test had been ordered for any reason, irrespective of the study
Who cannot join
- newborns with congenital diseases
- newborns transferred to pediatric wards for reasons unrelated to neonatal jaundice
- newborns who had undergone phototherapy
Trial locations and contacts
1 site in 1 country.
About this study
The performance and accuracy of the smartphone application (app) Picterus Jaundice Pro (PicterusJP) will be validated by a cross-sectional study conducted in low resource settings in Mexico. Physics-based and machine learning-based models will be used to analyze the images obtained with the app and its performance will be compared.
Read the detailed description
A cross-sectional prospective study is taken place at Hospital General de Zona 1 in the city of Oaxaca, Mexico.
Participants are recruited from the maternity ward and emergency room and data collection is conducted by one experienced pediatrician and one paediatrics' resident. After informed consent is obtained, background data including time and date or birth, birth weight, gestational age, parent's skin type according to Fitzpatrick scale and newborn's skin color according to Neomar's scale is being collected. Visual assessment is performed by the researchers using Kramer's scale. To obtain the bilirubin measurements with the smartphone app Picterus Jaundice Pro (Picterus JP), the calibration card is placed on the newborn's chest and a set of six images, 3 with and 3 without flash, are captured. The smartphones used to capture the images are Samsung A23, iPhone 11 and iPhone 15 Pro.
Total serum bilirubin (TSB) levels are measured with a blood sample obtained within one hour of capturing the images and analyzed at the hospital laboratory facilities.
Demographic and clinical characteristics will be analyzed by descriptive statistic.
Bilirubin measurements correlation between Picterus JP using both models and TSB will be determined by Pearson's correlation coefficient. Systematic over or underestimation of bilirubin levels will be evaluated using Bland-Altman plots. Accuracy measurements will be determined using receiver operating characteristics (ROC) and area under the curve (AUC) analysis. To compare the correlations from both models, Fisher's r to z transformation approach will be applied
- Conditions
- Jaundice, Neonatal
- Being tested
- Screening for neonatal jaundice with a mobile health device
- Keywords
- Neonatal jaundice, Screening, mobile health, low resource settings
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for neonatal jaundice with a mobile health deviceDevice
Picterus Jaundice Pro will be used to screen for neonatal jaundice by taking 6 photos of the newborns skin, where the Picterus calibration card is place.
| Study group | Role | What they receive |
|---|---|---|
| Screening for neonatal jaundice with a mobile health device | Experimental | Neonatal jaundice will be screened using the app Picterus JP and the results will be compared to the total serum bilirubin level from a blood test. Receives: Device: Screening for neonatal jaundice with a mobile health device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enable high qualitative estimation of bilirubin levels in the blood of Mexican newborns using Picterus JP
Evaluate the smartphone-based screening tool Picterus for neonatal jaundice in Mexican newborns.
Measured: 16 months
Secondary outcomes (1)
Correlation between bilirubin measurements with Picterus JP and total serum bilirubin
Pearson correlation coefficient
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start17 Jan 2023
- Primary completion8 Jun 2024
- Study completion8 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Jaundice, NeonatalStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Picterus AS, Instituto Mexicano del Seguro Social
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276582
- Sponsor's protocol ID
- 519379-2
- Status last verified
- Aug 2024
- First submitted
- 5 Feb 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jimenez-Diaz G, Gierman LM, Keitsch M, Elizarraras-Rivas J, Silva-Mendez RM, Infanti JJ, Marcuzzi A. Validation of a Mobile Health Device for Neonatal Jaundice Screening: A Cross-Sectional Study in a Resource-Limited Setting in Mexico. Sage Open Pediatr. 2025 Apr 22;12:30502225251320544. doi: 10.1177/30502225251320544. eCollection 2025 Jan-Dec.
PubMed 40612198
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Neonatal Jaundice With a Mobile Health Device: a Validation Study in Oaxaca, Mexico.
- ClinicalTrials.gov ID
- NCT06276582
- Acronym / sponsor ID
- 519379-2
- Conditions
- Jaundice, Neonatal
- Keywords
- Neonatal jaundice, Screening, mobile health, low resource settings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Picterus AS, Instituto Mexicano del Seguro Social
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 8 Jun 2024 (actual)
- Study completion
- 8 Jun 2024 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The performance and accuracy of the smartphone application (app) Picterus Jaundice Pro (PicterusJP) will be validated by a cross-sectional study conducted in low resource settings in Mexico. Physics-based and machine learning-based models will be used to analyze the images obtained with the app and its performance will be compared.
Detailed description
A cross-sectional prospective study is taken place at Hospital General de Zona 1 in the city of Oaxaca, Mexico.
Participants are recruited from the maternity ward and emergency room and data collection is conducted by one experienced pediatrician and one paediatrics' resident. After informed consent is obtained, background data including time and date or birth, birth weight, gestational age, parent's skin type according to Fitzpatrick scale and newborn's skin color according to Neomar's scale is being collected. Visual assessment is performed by the researchers using Kramer's scale. To obtain the bilirubin measurements with the smartphone app Picterus Jaundice Pro (Picterus JP), the calibration card is placed on the newborn's chest and a set of six images, 3 with and 3 without flash, are captured. The smartphones used to capture the images are Samsung A23, iPhone 11 and iPhone 15 Pro.
Total serum bilirubin (TSB) levels are measured with a blood sample obtained within one hour of capturing the images and analyzed at the hospital laboratory facilities.
Demographic and clinical characteristics will be analyzed by descriptive statistic.
Bilirubin measurements correlation between Picterus JP using both models and TSB will be determined by Pearson's correlation coefficient. Systematic over or underestimation of bilirubin levels will be evaluated using Bland-Altman plots. Accuracy measurements will be determined using receiver operating characteristics (ROC) and area under the curve (AUC) analysis. To compare the correlations from both models, Fisher's r to z transformation approach will be applied
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening for neonatal jaundice with a mobile health device | Experimental | Device: Screening for neonatal jaundice with a mobile health deviceNeonatal jaundice will be screened using the app Picterus JP and the results will be compared to the total serum bilirubin level from a blood test. |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- gestational age of 37 weeks or more
- birth weight of 2500 g and above
- newborns in whom a blood test had been ordered for any reason, irrespective of the study
Key exclusion criteria (3 listed)
- newborns with congenital diseases
- newborns transferred to pediatric wards for reasons unrelated to neonatal jaundice
- newborns who had undergone phototherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening for neonatal jaundice with a mobile health devicePicterus Jaundice Pro will be used to screen for neonatal jaundice by taking 6 photos of the newborns skin, where the Picterus calibration card is place. | Device | Screening for neonatal jaundice with a mobile health device |
Primary outcome
Enable high qualitative estimation of bilirubin levels in the blood of Mexican newborns using Picterus JP
Time frame: 16 months
Evaluate the smartphone-based screening tool Picterus for neonatal jaundice in Mexican newborns.
1 secondary outcome
Correlation between bilirubin measurements with Picterus JP and total serum bilirubin
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Derived from this study: PubMed 40612198Jimenez-Diaz G, Gierman LM, Keitsch M, Elizarraras-Rivas J, Silva-Mendez RM, Infanti JJ, Marcuzzi A. Validation of a Mobile Health Device for Neonatal Jaundice Screening: A Cross-Sectional Study in a Resource-Limited Setting in Mexico. Sage Open Pediatr. 2025 Apr 22;12:30502225251320544. doi: 10.1177/30502225251320544. eCollection 2025 Jan-Dec.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening for neonatal jaundice with a mobile health device in people with Jaundice, Neonatal, run by Norwegian University of Science and Technology at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enable high qualitative estimation of bilirubin levels in the blood of Mexican newborns using Picterus JP (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06276582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.