Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Dec 1, 2022

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.