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Completed

NCT Number: NCT06276582

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

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.

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Key information

Conditions

Jaundice, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General de Zona 1

Oaxaca City, 68040, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Screening for neonatal jaundice with a mobile health device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Correlation between bilirubin measurements with Picterus JP and total serum bilirubin

    Time frame: 2 hours

    Pearson correlation coefficient

Other outcomes

  1. Accuracy of Picterus JP to screen for neonatal jaundice

    Time frame: 16 months

    Sensitivity, specificity, positive and negative predictive values

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Instituto Mexicano del Seguro Social
  • Picterus AS

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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