Recruiting

NIRS

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT04106479

Conditions

Congenital Heart Defect

Single-ventricle

Coarctation of Aorta

Atrioventricular Canal

Hypoplastic Left Heart

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

NIRS evaluation

Study Details

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 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.

Conditions

Congenital Heart Defect

Single-ventricle

Coarctation of Aorta

Atrioventricular Canal

Hypoplastic Left Heart

Study ID

NCT04106479

Start date

Oct 11, 2019

Status verified date

Jun, 2025

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Apr 1, 2023

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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 Parental consent can be withdrawn at any time during the study.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

NIRS evaluation

NIRS will be used for measurement of cerebral and renal saturation.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Gabriel Altit, MD

514-412-4452gabriel.altit@mcgill.ca

Jennifer Gardner

514-412-4400jennifer.gardner@muhc.mcgill.ca

Locations

Mcgill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Gabriel Altit, MD

514-412-4452gabriel.altit@mail.mcgill.ca

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Jun 17, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2025-06-17.