Improving Critical Congenital Heart Disease Screening With Addition of Perfusion Measurements

Completed · Not applicable

Conditions studied: Congenital Heart Disease

In brief

The purpose of this research is to evaluate and create a new clinical prediction model for CCHD screening that combines non-invasive measurements of oxygenation and perfusion.

Key facts

Study ID

NCT04056104

Run by

University of California, Davis

People needed

543

Starts

2019-10-23

Expected to finish

2021-12-12

Last updated by the study team

2022-02-03

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age < 22 days
• and either: a) asymptomatic newborn undergoing SpO2 screening for CCHD, or 2b) newborn prenatally or postnatally diagnosed/suspected with CHD.

You may not qualify if…

• For Controls: 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 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 it is running

• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Sutter Institute for Medical Research — Sacramento, California, United States
• University of California-Davis — Sacramento, California, United States
• UCSF Benioff Children's Hospital — San Francisco, California, United States
• Northwell Health — New Hyde Park, New York, United States
• University of Utah/Primary Children's Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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