The Arch Watch Study: An Integrated Evaluation of Hemodynamics in Infants With Suspected Coarctation of the Aorta

Conditions

• Aortic Arch Obstruction
• Coarctation of the Aorta

Eligibility Criteria

Sex

ALL

Age

0 Days - 60 Days

Healthy Volunteers

Accepted

Interventions

• Monitoring using resonance Raman spectroscopy, pulse oximetry, blood pressure, and near-infrared spectroscopy — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Oct 1, 2023

Status verified

Aug 2024

Primary completion

Jun 1, 2025

Completion

Jun 30, 2025

Study Design

Enrollment

60 participants (estimated)

Primary Outcome Measure

Number of participants with arch or CoA repair [ Time Frame: First 3 postnatal months ]

Locations (1)

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