An observational study in Coarctation of the Aorta and Aortic Arch Obstruction, sponsored by Boston Children's Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 0 Days to 60 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Boston Children's Hospital · Observational
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.
Coarctation of the aorta (CoA) is a potentially life-threatening form of congenital heart disease (CHD) in which an anatomic narrowing of the aortic arch may cause critical aortic arch obstruction (AAO) following closure of the ductus arteriosus (DA). CoA accounts for 6-8% of all CHD and occurs in about 1 in every 1800 babies born in the United States each year. Despite this prevalence, CoA frequently eludes detection on both prenatal imaging and CHD screening. If undiagnosed, infants may present with catastrophic shock, often leading to mortality or severe morbidities. In many cases, the anatomic appearance of the aortic arch in the fetal or early postnatal period raises suspicion for AAO that can only be confirmed by allowing the DA to become restrictive and closely monitoring for hemodynamic changes. However, the process of monitoring hemodynamics during ductal closure (MHDC, i.e. the 'arch watch') is variable across institutions and can be insensitive to critical deficiencies in oxygen delivery in the setting of decreased blood flow, even in subspecialized ICU environments. Current approaches to monitoring hemodynamic changes in neonates with possible AAO revolve around non-invasive measurements of oxygen saturation (i.e. pulse oximetry, near infrared spectroscopy (NIRS)) and tissue perfusion (i.e. femoral pulse strength, urine output, blood pressure). There are no publications which systematically and concurrently assess these trends during this hemodynamic transition, and as such, there are no agreed upon thresholds to alert clinicians that a developing AAO is causing impaired tissue perfusion/oxygenation. Exploration of traditional measures of tissue oxygenation may prove more sensitive and specific at identifying compromise in newborns with critical AAO. For example, certain pulse oximetry waveform characteristics (photoplethysmography, PPG) have shown differences in healthy newborns versus those with CoA. Resonance Raman spectroscopy (RRS) is another validated non-invasive method that assesses peripheral tissue oxygenation in neonates and has been shown to correlate well with invasive markers of tissue oxygenation. The investigators and others have utilized RRS in healthy neonates and in animals to detect tissue hypoperfusion. To test the hypothesis that a validated MHDC process that combines 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 AAO, the investigators identified the following aims:
Aim I: To assess the reliability of currently deployed non-invasive markers of tissue oxygenation/perfusion (femoral pulse strength, pre- vs. post- ductal blood pressure and saturation gradient, cerebral/renal NIRS, and urine output) in identifying a critical AAO that will need intervention in the newborn period.
Aim II: To explore the sensitivity of PPG to identify critical AAO requiring intervention in the newborn period.
Aim III: To determine the feasibility of assessing oxygen utilization at the tissue level based on RRS during MHDC and examine its predictive capability in identifying those infants with AAO who will require arch intervention in the newborn period.
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 29 observational studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Infants with prenatal or postnatal echocardiographic findings concerning for or diagnostic of aortic arch obstruction admitted to the BCH CICU.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Number of participants with arch or CoA repair
Surgical or catheter-based repair of the aortic arch or coarctation of the aorta
Time frame: First 3 postnatal months
Number of participants with echocardiographic finding of aortic arch obstruction
Echocardiographic finding of aortic arch obstruction defined as blunted doppler in the descending aorta or presence of pathognomonic characteristic of CoA such as clear posterior shelf
Time frame: 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
Necrotizing enterocolitis will be defined as the presence of pneumatosis intestinalis as documented in an attending-read radiology report. Acute kidney injury will be defined per modified neonatal KDIGO guidelines of stage I or greater AKI (serum creatinine SCr rise of greater than 0.3 mg/dL within 48 hours or SCr rise greater than 1.5-1.9x baseline SCr within 7 days) or if no creatinine data are present for the patient, then using urine output criteria of less than or equal to 1 ml/kg/hr of urine output for 24 hours.
Time frame: First 3 postnatal months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.