An observational study in Congenital Heart Defect, Single-ventricle and Coarctation of Aorta, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Recruiting at 1 site in Canada. Open to participants aged 0 Days to 7 Days. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Observational
Neonatal patients with congenital heart defects (CHD) have changing physiology in the context of transitional period. Patients with CHD are at risk of low perfusion status or abnormal pulmonary blood flow. Near infrared spectroscopy has been used in neonatal intensive care units (NICU) to measure end-organ perfusion. The investigator plan on monitoring newborns with CHD admitted to the NICU with NIRS and echocardiography during the first week of life and correlate measures of perfusion from Dopplers to cerebral and renal NIRS.
Near infrared spectroscopy (NIRS) is a noninvasive technology that uses infrared light to measure Oxygen levels in tissue or organs. However, the use of this monitoring tool has not been the standard of care in the immediate post-natal life. The investigator wish to study this way of monitoring Oxygen, which consists of using a sticker on the skin of the forehead and the skin of the abdomen to continuously monitor the Oxygen content of the brain and the kidneys and compare NIRS values in the CHD population to echocardiographic measures of blood flow and heart function to see if/how this simple, non-invasive tool could help us to closely monitor Oxygen in babies with CHD.
The NIRS probe (sticker) will be put on the side of the abdomen (the flank to monitor the kidney saturation of oxygen) and on the forehead (to monitor the brain saturation of oxygen) for 7 days or until the baby is discharged home, has a procedure in cath-lab or has surgery. An echocardiography will take place daily (for up to 7 days, or up to discharge, or up to cardiac intervention) during the day and should last about 15- 20 minutes. Newborns will be recruited during the fetal consultation with the cardiologist or neonatologist; or will be recruited during their neonatal admission. Only newborns admitted to the NICU will be eligible to the study.
The investigator would like to better understand the way babies with cardiac conditions transition once they are born and into their first week of life. During that important time, there are a lot of changes that can impact the cardiac adaptation: vessels in the lungs that relax, vessels in the body that contract. Echocardiography and NIRS may help us better appreciate these changes by evaluating the delivery of oxygen to organs. Echocardiography may reveal some information about this adaptation by looking at the cardiac performance by ultrasound and blood flow patterns.
Approximately 100 participants from this hospital will take part in this study.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
This study's planned enrollment of 100 is below the median of 119 across 440 observational studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 421 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All newborns with tetralogy of fallot, truncus arteriosus, D-transposition of great arteries, PS, AS, coarctation of the aorta, DILV, AVC, DORV, HLHS, TA and PAIVS consecutively admitted at our institution (Montreal Children's Hospital) neonatal intensive care unit (NICU) from January 2018 to January 2020.
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.
A prospective study will be conducted of all newborns with tetralogy of fallot, trucus arteriosus, D-transposition of great arteries, PS, AS, coarctation of the aorta, DILV, AVC, DORV, HLHS, TA and PAIVS consecutively admitted at our institution (Montreal Children's Hospital) neonatal intensive care unit (NICU) from January 2018 to January 2020. Patients with CHD will be compared to a control population of term infants admitted and monitored in the NICU with antenatal suspicion of coarctation, ruled-out postnatally.
Exclusion Criteria:
Patients will be excluded if premature less than 34 weeks of estimated gestational age (GA) at birth or if parents do not consent. Parental consent can be withdrawn at any time during the study.
NIRS will be used for measurement of cerebral and renal saturation.
Correlation between cerebral saturation and ACA doppler
Time frame: Measures from Day 0 to Day7
Correlation between aortic doppler and renal NIRS measures
Time frame: Measures from Day 0 to Day7
Correlation between LV performance by STE and Csat and Rsat by NIRs
Time frame: Measures from Day 0 to Day7
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet 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.
McGill University Health Centre/Research Institute of the McGill University Health Centre →