Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements (NCT05637814) | Clinical Trial Compass
RecruitingNot Applicable
Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements
United States320 participantsStarted 2023-08-17
Plain-language 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.
Who can participate
Age range
0 Minutes – 21 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area under the curve for receiver operating characteristics for critical congenital heart disease using ML inpatient algorithm.
Timeframe: Through study completion, an average of 4 years