About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SpO2/PIx Measurement and ML Algorithm
Treatment groups
Sponsors and collaborators
University of California, Davis
Lead sponsor
National Institutes of Health (NIH)
Collaborator