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.

Interested in this trial?

Get notified about updates and connect with the research team.

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)

UC Davis Medical Center

Davis, California, United States

Cohen Children's Medical Center

Queens, New York, United States

University of Utah Health Care

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05637814


Related Trials