Home › Congenital Heart Defects › NCT05637814
Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements
RecruitingHealthy volunteers welcome
Who can join
0 Minutes – 21 Days · All sexes · Healthy volunteers welcome
Full 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.
About the study
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.
What is being tested
- SpO2/PIx Measurement and ML Algorithm (diagnostic test)
Sponsor: University of California, Davis · Participants: 320 · Started: Aug 17, 2023
Contact the study team
- Heather Siefkes, MD, MSCI · Phone: 916-713-7697
- Elva Horath, IMG · Phone: 916-713-7697
Official record on ClinicalTrials.gov — NCT05637814
Locations in the U.S.
| California | UC Davis Medical Center, Davis |
| New York | Cohen Children's Medical Center, Queens (Not yet recruiting) |
| Utah | University of Utah Health Care, Salt Lake City (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.