Congenital Heart DefectSingle-ventricleCoarctation of AortaAtrioventricular CanalHypoplastic Left HeartTransposition of Great VesselsInterrupted Aortic ArchTricuspid AtresiaPulmonary AtresiaAortic AtresiaTetralogy of Fallot
Investigational drug(s) / intervention(s)
NIRS evaluation
NIRS evaluation: NIRS will be used for measurement of cerebral and renal saturation.
Study 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 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.
Eligibility
Sex
ALL
Min age
0 Days
Max age
7 Days
Healthy volunteers
No
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 Parental consent can be withdrawn at any time during the study.
Primary outcome measure(s)
Correlation between cerebral saturation and ACA doppler — Measures from Day 0 to Day7
Correlation between aortic doppler and renal NIRS measures — Measures from Day 0 to Day7
Trial sites (1)
Facility
City
Region
Status
Mcgill University Health Centre
Montreal
Quebec
Recruiting
More McGill University Health Centre/Research Institute of the McGill University Health Centre trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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