Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements
Congenital Heart Disease
About this trial
This is an interventional diagnostic trial for Congenital Heart Disease focused on measuring Machine Learning Algorithm, Pulse Oximetry
Eligibility Criteria
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.
Sites / Locations
- UC Davis Medical CenterRecruiting
- Cohen Children's Medical Center
- University of Utah Health Care
Arms of the Study
Arm 1
Experimental
SpO2 and PIx Measurement
Non-invasive measurements of oxygenation (SpO2) and perfusion (PIx) will be measured with pulse oximeters and a ML CCHD screening algorithm will be assigning a prediction every minute.