Taking people in United StatesNo phase
Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements
Key facts
- Who runs it
- University of California, Davis
- Where
- Davis, Queens, and Salt Lake City, United StatesSee the 3 sites
- Trial code
- Status
- Recruiting
- People taking part
- 320 people, planned
- Started
- 17 Aug 2023
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional
- Treatments tested
- SpO2/PIx Measurement and ML Algorithm
- Record updated
- 18 June 2026
Who can take part
- Age
- 0 Minutes to 21 days
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in United States
- UC Davis Medical CenterDavis, United StatesContact: Heather Siefkes, MD, MSCITaking people
- Cohen Children's Medical CenterQueens, United StatesContact: Robert Koppel, MDNot yet recruiting
- University of Utah Health CareSalt Lake City, United StatesContact: Whitnee Hogan, MDNot yet recruiting
About the trial
What the trial wants to find out
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.
The group in the trial
- SpO2 and PIx MeasurementTreatment being tested
Non-invasive measurements of oxygenation (SpO2) and perfusion (PIx) will be measured with pulse oximeters and a ML CCHD screening algorithm will be assigning a prediction every minute.
Treatment: SpO2/PIx Measurement and ML Algorithm
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 18 June 2026