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RECRUITING
NCT05637814
NA

Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements

Sponsor: University of California, Davis

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

0 Minutes - 21 Days

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2023-08-17

Completion Date

2027-12-31

Last Updated

2026-06-18

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

SpO2/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 Center

Davis, California, United States

Cohen Children's Medical Center

Queens, New York, United States

University of Utah Health Care

Salt Lake City, Utah, United States