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

NCT05880576 | Enrolling By Invitation

• 1 other identifier: P00044159
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of participants with arch or CoA repair

  Surgical or catheter-based repair of the aortic arch or coarctation of the aorta

  First 3 postnatal months

Secondary Outcomes (2)

• Number of participants with echocardiographic finding of aortic arch obstruction

  First 3 postnatal months

• Number of participants with end organ damage as evidence by necrotizing enterocolitis, or acute kidney injury in the first three postnatal months

  First 3 postnatal months

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.

Eligibility Criteria

• Age: 0 Days - 60 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants with prenatal or postnatal echocardiographic findings concerning for or diagnostic of aortic arch obstruction admitted to the BCH CICU.

You may qualify if:

• Infants with echocardiography-based possible or definite aortic arch obstruction and \<1 month postnatal age admitted to the CICU

You may not qualify if:

• Known carrier status for resistant organisms. Resistant organisms are defined as MRSA and VRE.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Aortic Coarctation

Interventions

Oximetry; Blood Pressure; Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques; Vital Signs; Physical Examination; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Diagnostic Imaging; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• John Kheir, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 30, 2023
• Study Start: October 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 30, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)