Screening for Neonatal Jaundice With a Mobile Health Device: a Validation

Status Recruiting

Clinical 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. Physics-based and machine learning-based models will be used to analyze the images obtained with the app and its performance will be compared.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06276582
Study type	Interventional
Source	Norwegian University of Science and Technology
Contact	Gabriela Jimenez Diaz
Phone	+4745914516
Email	gabriela.j.diaz@ntnu.no
Status	Recruiting
Phase	N/A
Start date	January 17, 2023
Completion date	May 31, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms