Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements
University of California, Davis
Summary
The purpose of this study is to implement and externally validate an inpatient ML algorithm that combines pulse oximetry features for critical congenital heart disease (CCHD) screening.
Description
The study will externally validate an algorithm that combines non-invasive oxygenation and perfusion measurements as a screening tool for CCHD. In a previous study, the investigators created an algorithm that combines non-invasive measurements of oxygenation and perfusion over at least two measurements using machine learning (ML) techniques. The prior model was created and tested using internal validation (k-fold validation). Thus, the investigators will test the model on an external sample of patients to test generalizability of the model. Additionally, the team will trial a repeated measurem…
Eligibility
- Age range
- 0–0 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Age \< 22 days * Fetuses suspected to have congenital heart disease * Newborns with suspected/confirmed critical congenital heart disease * Asymptomatic newborn undergoing SpO2 screening for CCHD Exclusion Criteria: * Echocardiogram completed prior to enrollment as the newborn would then no longer be considered "asymptomatic undergoing SpO2 screening for CCHD" * For Newborns with confirmed/suspected congenital heart disease (CHD): a) Patent ductus arteriosus and/or atrial septal defect/patent foramen ovale without other defects, b) Corrective cardiac surgical or cathet…
Interventions
- Diagnostic TestSpO2/PIx Measurement and ML Algorithm
Right upper and any lower extremity oxygen saturation (SpO2) and perfusion index (PIx) will be measured and an online ML inference model will be used to classify a newborn as healthy versus CCHD as new pulse oximetry data is collected.
Locations (3)
- UC Davis Medical CenterDavis, California
- Cohen Children's Medical CenterQueens, New York
- University of Utah Health CareSalt Lake City, Utah