Monitoring oxygen levels in newborns with congenital heart defects
Official title: Do Cerebral and Renal Saturations Measured With Near-infrared Spectroscopy Correlate With Echocardiographic Markers of Perfusion and Cardiac Performance in Congenital Heart Disease?
Run by McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT04106479 · Data updated 2026-11-12
This study is testing a new way to monitor oxygen levels in newborns with congenital heart defects to see how it can help doctors understand their heart and blood flow better.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Days to 7 Days |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Status | Recruiting |
| Started | October 11, 2019 |
| Main results expected | April 1, 2023 |
| Study ends | December 1, 2025 |
| Registry record updated | June 17, 2025 |
| Trial ID | NCT04106479 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are newborns diagnosed with various congenital heart defects admitted to the neonatal intensive care unit.
✕Probably not a fit
Patients who are premature (less than 34 weeks gestational age) or whose parents do not consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to monitor neonatal patients with congenital heart defects (CHD) using near infrared spectroscopy (NIRS) and echocardiography during their first week of life. The study will involve placing NIRS probes on the forehead and abdomen of newborns to continuously measure oxygen levels in the brain and kidneys. Daily echocardiograms will be performed to correlate blood flow and heart function with NIRS measurements. The goal is to better understand the physiological changes in newborns with CHD and assess the potential of NIRS as a non-invasive monitoring tool.
Why it matters
Potential benefit: If successful, this study could improve the monitoring of oxygen levels in newborns with congenital heart defects, leading to better clinical outcomes.
How similar studies have gone: While the use of NIRS in this specific context is novel, similar studies have shown promise in using non-invasive monitoring techniques for assessing oxygen levels in other patient populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 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.
Where it's running
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Mcgill University Health Centre
Montreal, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Gabriel Altit — McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study coordinator: Gabriel Altit, MD
- Email: gabriel.altit@mcgill.ca
- Phone: 514-412-4452
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.