RecruitingNot ApplicableNCT05637814
Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements
Sponsor
University of California, Davis
Enrollment
320 participants
Start Date
Aug 17, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 0 MinutesMax Age: 21 Days
Inclusion Criteria4
- 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 Criteria2
- 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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Interventions
DIAGNOSTIC_TESTSpO2/PIx Measurement and ML Algorithm
Right upper and any lower extremity oxygen saturation (SpO2) and perfusion index (PIx) will be measured and an online ML inference model will be used to classify a newborn as healthy versus CCHD as new pulse oximetry data is collected.
Locations(3)
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NCT05637814
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