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The Arch Watch Study: An Integrated Evaluation of Hemodynamics in Infants With Suspected Coarctation of the Aorta
Sponsor: Boston Children's Hospital
Summary
Unrecognized coarctation of the aorta (CoA) is a life-threatening component of congenital heart disease (CHD) in which narrowing of the aorta causes obstructed blood flow to the lower half of the body; it can occur in isolation or in combination with other defects. CoA is the type of CHD most likely to be missed by current newborn screening. An evolving coarctation (during closure of the ductus arteriosus) can be challenging to diagnose until often devastating end-organ injury manifests, even in the ICU setting. This study will evaluate currently used tools, such as four extremity blood pressures and pulse oximetry, and the investigators will test new tools - resonance Raman spectroscopy (RRS) and photoplethysmography analysis- to assess the adequacy of oxygen delivery in newborns who are at risk for aortic arch obstruction. The investigators hypothesize that combining an assessment of commonly used non-invasive monitoring tools, new components of these traditional tools, and RRS, will have improved sensitivity in detecting critical impairments to tissue oxygen delivery in newborns with suspected critical aortic arch obstruction.
Official title: The Arch Watch Study: An Integrated Evaluation of Hemodynamics During Monitoring of Ductus Arteriosus Closure in Infants With Suspected Coarctation of the Aorta
Key Details
Gender
All
Age Range
0 Days - 60 Days
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2023-10-01
Completion Date
2025-06-30
Last Updated
2024-08-20
Healthy Volunteers
Yes
Interventions
Monitoring using resonance Raman spectroscopy, pulse oximetry, blood pressure, and near-infrared spectroscopy
Infants will have monitoring three times a day with resonance Raman spectroscopy device during arch watch period. They will have continuous monitoring with pulse oximetry and near infrared spectroscopy. They will have intermittent blood pressure monitoring.
Locations (1)
Boston Children's Hospital
Boston, Massachusetts, United States