NCT05637814 Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements
| NCT ID | NCT05637814 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Davis |
| Condition | Congenital Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2023-08-17 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 320 participants in total. It began in 2023-08-17 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05637814 clinical trial?
This trial is open to participants of all sexes, aged 0 Minutes or older, up to 21 Days, studying Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05637814 currently recruiting?
Yes, NCT05637814 is actively recruiting participants. Contact the research team at hsiefkes@ucdavis.edu for enrollment information.
Where is the NCT05637814 trial being conducted?
This trial is being conducted at Davis, United States, Queens, United States, Salt Lake City, United States.
Who is sponsoring the NCT05637814 clinical trial?
NCT05637814 is sponsored by University of California, Davis. The trial plans to enroll 320 participants.