Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-21
SponsorUniversity of California, Davis

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

320 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of California, Davis

Lead sponsor

National Institutes of Health (NIH)

Collaborator