NIRS in Congenital Heart Defects - Correlation With Echocardiography

NCT04106479 | Recruiting FDA Device

• 1 other identifier: 2018-3823
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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; Transposition of Great Vessels; Interrupted Aortic Arch; Tricuspid Atresia; Pulmonary Atresia; Aortic Atresia; Tetralogy of Fallot

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Correlation between LV performance by STE and Csat and Rsat by NIRs

  Measures from Day 0 to Day7

Interventions

NIRS evaluation DEVICE

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

Eligibility Criteria

• Age: 0 Days - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Medtronic: collaborator

Study Sites (1)

Mcgill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Related Publications (1)

• Altit G, Bhombal S, Chock VY. End-organ saturations correlate with aortic blood flow estimates by echocardiography in the extremely premature newborn - an observational cohort study. BMC Pediatr. 2021 Jul 12;21(1):312. doi: 10.1186/s12887-021-02790-1.

  PMID: 34253175 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Univentricular Heart; Aortic Coarctation; Endocardial Cushion Defects; Hypoplastic Left Heart Syndrome; Transposition of Great Vessels; Tricuspid Atresia; Pulmonary Atresia; Tetralogy of Fallot

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Septal Defects; Heart Valve Diseases; Vascular Malformations

Study Officials

• Gabriel Altit

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Altit, MD

CONTACT

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

Jennifer Gardner

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: October 11, 2019
• Primary Completion: April 1, 2023
• Study Completion: December 1, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)