Screening for Neonatal Jaundice With a Mobile Health Device: a Validation Study in Oaxaca, Mexico.

August 9, 2024 updated by: Norwegian University of Science and Technology
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

177

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Oaxaca, Mexico, 68040
        • Hospital General de Zona 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • newborns with congenital diseases
  • newborns transferred to pediatric wards for reasons unrelated to neonatal jaundice
  • newborns who had undergone phototherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Screening for neonatal jaundice with a mobile health device
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.
Device: Screening for neonatal jaundice with a mobile health device
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between bilirubin measurements with Picterus JP and total serum bilirubin
Time Frame: 2 hours
Pearson correlation coefficient
2 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Picterus JP to screen for neonatal jaundice
Time Frame: 16 months
Sensitivity, specificity, positive and negative predictive values
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

Instituto Mexicano del Seguro Social
Picterus AS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2023

Primary Completion (Actual)

June 8, 2024

Study Completion (Actual)

June 8, 2024

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 9, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 519379-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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