NCT05880576|Enrolling By Invitation
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Sponsor study identifier
observational
60
1 country
1
Study Start
October 1, 2023
Actual (reported)Primary Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 19, 2023
Actual (reported)May 30, 2023
Actual (reported)October 1, 2023
Actual (reported)December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Infants with prenatal or postnatal echocardiographic findings concerning for or diagnostic of aortic arch obstruction admitted to the BCH CICU.
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
John Kheir, MD
Boston Children's Hospital
First Submitted
May 19, 2023
First Posted
May 30, 2023
Study Start
October 1, 2023
Actual (reported)Primary Completion
December 1, 2026
EstimatedA Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 29, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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