Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements
Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Dec 1, 2022
Trial Information
Current as of January 14, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new way to screen for a serious heart condition called critical congenital heart disease (CCHD) in newborns and young children. The study aims to use a special computer program that analyzes certain measurements from a simple test called pulse oximetry, which checks how well oxygen is being carried in the blood. The goal is to see if this new method can help identify CCHD more effectively, ensuring that affected babies receive the care they need as early as possible.
To participate in this trial, babies must be 22 days old or younger and may include those who are suspected to have congenital heart disease or are asymptomatic (showing no symptoms) while undergoing routine screening. However, certain conditions, such as having had specific heart procedures or being on certain medications, may exclude them from the trial. If eligible, participants will undergo regular monitoring and testing to help researchers assess the effectiveness of this new screening approach. This study is currently recruiting participants of all genders, and it represents an important step in improving heart health for infants and children.
Gender
ALL
Eligibility 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.
About University Of California, Davis
The University of California, Davis (UC Davis) is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials and studies. With a strong focus on interdisciplinary collaboration, UC Davis leverages its extensive expertise in medical research, education, and patient care to drive breakthroughs in various fields, including medicine, public health, and agriculture. The university's clinical trial programs emphasize rigorous scientific methodology and ethical standards, aiming to translate research findings into impactful treatments and improved patient outcomes. Through its state-of-the-art facilities and a dedicated team of researchers and healthcare professionals, UC Davis is at the forefront of transforming healthcare practices and addressing critical health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Davis, California, United States
Queens, New York, United States
Salt Lake City, Utah, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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