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NIRS in Congenital Heart Defects - Correlation With Echocardiography

NCT04106479 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-06-17

No results posted yet for this 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.

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

Interventions

DEVICE

NIRS evaluation

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

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

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

    lead OTHER

Principal Investigators

  • Gabriel Altit · McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility

Min Age
0 Days
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-11
Primary Completion
2023-04-01
Completion
2025-12-01
FDA Device
Yes

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04106479 on ClinicalTrials.gov