Screening for critical congenital heart disease using a machine learning algorithm
Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements
This study is testing a new computer program to see if it can better screen newborns for serious heart problems using simple measurements like blood oxygen levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 0 Minutes to 21 Days |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 3 sites (Davis, California and 2 other locations) |
| Trial ID | NCT05637814 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a machine learning algorithm that combines pulse oximetry and perfusion measurements to screen for critical congenital heart disease (CCHD) in newborns. The algorithm was previously developed and tested internally, and this study will assess its effectiveness on an external patient sample. The approach includes repeated measurements to improve detection rates while minimizing false positives. The goal is to enhance the screening process for CCHD, which can be life-threatening if not detected early.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns under 22 days old who are suspected of having congenital heart disease or are asymptomatic and undergoing SpO2 screening for CCHD.
Not a fit: Patients who have already undergone an echocardiogram or have specific types of congenital heart defects may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of critical congenital heart disease in newborns, potentially saving lives.
How similar studies have performed: Previous studies have shown promise in using machine learning algorithms for similar screening approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Davis, California and 2 other locations
- UC Davis Medical Center — Davis, California, United States (Recruiting)
- Cohen Children's Medical Center — Queens, New York, United States (Not_yet_recruiting)
- University of Utah Health Care — Salt Lake City, Utah, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Heather Siefkes, MD, MSCI
- Email: hsiefkes@ucdavis.edu
- Phone: 916-713-7697
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.