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โ† Trials
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Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements

RecruitingNAAges 0 Minutes - 21 DaysAllUniversity of California, Davis
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • SpO2/PIx Measurement and ML Algorithm
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Where

3 sites
UC Davis Medical Center
Davis, United States
Cohen Children's Medical Center
Queens, United States
University of Utah Health Care
Salt Lake City, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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