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NCT05637814
Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements
Conditions: Congenital Heart Disease
Sex: All
Ages: 0 Minutes – 21 Days
Healthy volunteers: 1
Phase: NA
Enrollment: 240
Sponsor: University of California, Davis
Location: United States
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 Criteria
Inclusion Criteria:Age < 22 daysFetuses suspected to have congenital heart diseaseNewborns with suspected/confirmed critical congenital heart diseaseAsymptomatic newborn undergoing SpO2 screening for CCHDExclusion 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.
Source: ClinicalTrials.gov (NCT05637814). StuddyBuddy aggregates publicly available trial information.