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Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements

University of California, Davis · with National Institutes of Health (NIH) · NCT05637814

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Up to age 1 mo · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
320
US sites recruiting
1
Study start
August 17, 2023
Record last updated
June 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: SpO2/PIx Measurement and ML Algorithm

Conditions: Congenital Heart Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • UC Davis Medical Center

    Davis, CA 95616

    Site contact: Heather Siefkes, MD, MSCI · hsiefkes@ucdavis.edu

Study contacts (from the official record)

  • Heather Siefkes, MD, MSCI · 916-713-7697 · hsiefkes@ucdavis.edu
  • Elva Horath, IMG · 916-713-7697 · ethorath@ucdavis.edu
All heart & blood pressure studies in California →
Dynamic Critical Congenital Heart Screening With Addition of… (NCT05637814) | Bored Studies