Screening for Neonatal Jaundice With a Mobile Health Device: a Validation Study in Oaxaca, Mexico.
1 other identifier
interventional
177
1 country
1
Brief 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. Physics-based and machine learning-based models will be used to analyze the images obtained with the app and its performance will be compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2023
CompletedFirst Submitted
Initial submission to the registry
February 5, 2024
CompletedFirst Posted
Study publicly available on registry
February 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 8, 2024
CompletedAugust 12, 2024
August 1, 2024
1.4 years
February 5, 2024
August 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
16 months
Secondary Outcomes (1)
Correlation between bilirubin measurements with Picterus JP and total serum bilirubin
2 hours
Other Outcomes (1)
Accuracy of Picterus JP to screen for neonatal jaundice
16 months
Study Arms (1)
Screening for neonatal jaundice with a mobile health device
EXPERIMENTALNeonatal 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- newborns with congenital diseases
- newborns transferred to pediatric wards for reasons unrelated to neonatal jaundice
- newborns who had undergone phototherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- Picterus AScollaborator
- Instituto Mexicano del Seguro Socialcollaborator
Study Sites (1)
Hospital General de Zona 1
Oaxaca City, 68040, Mexico
Related Publications (1)
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.
PMID: 40612198DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2024
First Posted
February 26, 2024
Study Start
January 17, 2023
Primary Completion
June 8, 2024
Study Completion
June 8, 2024
Last Updated
August 12, 2024
Record last verified: 2024-08