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Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements

RECRUITINGN/ASponsored by University of California, Davis
Actively Recruiting
PhaseN/A
SponsorUniversity of California, Davis
Started2023-08-17
Est. completion2027-06-30
Eligibility
Age0 Minutes – 21 Days
Healthy vol.Accepted
Locations3 sites

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.

Eligibility

Age: 0 Minutes – 21 DaysHealthy volunteers accepted
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 catheter intervention performed before enrollment or c) Current infusions of vasoactive medications other than prostaglandin therapy.

Conditions2

Congenital Heart DiseaseHeart Disease

Locations3 sites

California

1 site
UC Davis Medical Center
Davis, California, 95616
Heather Siefkes, MD, MSCIhsiefkes@ucdavis.edu

New York

1 site
Cohen Children's Medical Center
Queens, New York, 11040
Robert Koppel, MDrkoppel@northwell.edu

Utah

1 site
University of Utah Health Care
Salt Lake City, Utah, 84102

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