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

NCT05880576 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-08-20

No results posted yet for this study

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.

Conditions

  • Coarctation of the Aorta
  • Aortic Arch Obstruction

Interventions

DEVICE

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.

Sponsors & Collaborators

Principal Investigators

  • John Kheir, MD · Boston Children's Hospital

Eligibility

Min Age
0 Days
Max Age
60 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2025-06-01
Completion
2025-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05880576 on ClinicalTrials.gov