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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-17

Study Completion Date

2024-06-08

Brief Summary

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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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Detailed Description

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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

Conditions

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Jaundice, Neonatal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Screening for neonatal jaundice with a mobile health device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No