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

Jaundice, Neonatal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06276582
• Other study ID #: 519379-2
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: February 2024
• Source: Norwegian University of Science and Technology
• Contact: Gabriela Jimenez Diaz
• Phone: +4745914516
• Email: gabriela.j.diaz[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Neonatal

Intervention

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.

Locations

Country	Name	City	State
Mexico	Hospital General de Zona 1	Oaxaca

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Instituto Mexicano del Seguro Social, Picterus AS

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Accuracy of Picterus JP to screen for neonatal jaundice	Sensitivity, specificity, positive and negative predictive values	16 months
Primary	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	Correlation between bilirubin measurements with Picterus JP and total serum bilirubin	Pearson correlation coefficient	2 hours