Status:
COMPLETED
Improving Critical Congenital Heart Disease Screening With Addition of Perfusion Measurements
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
Up to 21 years
Phase:
NA
Brief Summary
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.
Detailed Description
This study will create and test an enhanced critical congenital heart defect (CCHD) screen that combines non-invasive measurements of oxygenation and perfusion in two ways. The first will use current ...
Eligibility Criteria
Inclusion
- Age \< 22 days
- and either: a) asymptomatic newborn undergoing SpO2 screening for CCHD, or 2b) newborn prenatally or postnatally diagnosed/suspected with CHD.
Exclusion
- 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.
Key Trial Info
Start Date :
October 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2021
Estimated Enrollment :
543 Patients enrolled
Trial Details
Trial ID
NCT04056104
Start Date
October 23 2019
End Date
December 12 2021
Last Update
February 3 2022
Active Locations (6)
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1
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
2
Sutter Institute for Medical Research
Sacramento, California, United States, 95816
3
University of California-Davis
Sacramento, California, United States, 95817
4
UCSF Benioff Children's Hospital
San Francisco, California, United States, 94158