Clinical trial NCT06276582: Screening for Neonatal Jaundice With a Mobile Health Device: a Validation Study in Oaxaca, Mexico.
Official title: Screening for Neonatal Jaundice With a Mobile Health Device: a Validation Study in Oaxaca, Mexico.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaundice, Neonatal
Keywords: Neonatal jaundice
Screening
mobile health
low resource settings
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Picterus AS
name: Instituto Mexicano del Seguro Social
First posted: 2024-02-26
Enrollment: 177
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Enable high qualitative estimation of bilirubin levels in the blood of Mexican newborns using Picterus JP
timeFrame: 16 months
Secondary outcomes:
measure: Correlation between bilirubin measurements with Picterus JP and total serum bilirubin
timeFrame: 2 hours
Other outcomes:
measure: Accuracy of Picterus JP to screen for neonatal jaundice
timeFrame: 16 months
Locations:
city: Oaxaca
country: Mexico
facility: Hospital General de Zona 1
Study officials:
References: