Status:
RECRUITING
NIRS in Congenital Heart Defects - Correlation With Echocardiography
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Medtronic
Conditions:
Congenital Heart Defect
Single-ventricle
Eligibility:
All Genders
Up to 7 years
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 Parental consent can be withdrawn at any time during the study.
Key Trial Info
Start Date :
October 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04106479
Start Date
October 11 2019
End Date
December 1 2025
Last Update
June 17 2025
Active Locations (1)
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1
Mcgill University Health Centre
Montreal, Quebec, Canada, H4A 3J1