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Search / Trial NCT04106479

NIRS in Congenital Heart Defects - Correlation With Echocardiography

Launched by MCGILL UNIVERSITY HEALTH CENTRE/RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE · Sep 25, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how well a special device called near infrared spectroscopy (NIRS) can help monitor blood flow and oxygen levels in newborns with congenital heart defects (CHD). These heart defects can affect how blood moves throughout the body, especially in the critical first week of life. The researchers will compare the results from NIRS with traditional heart imaging tests called echocardiograms to see how well they match up. This could help doctors better understand how to care for these newborns.

To participate in the trial, babies must be diagnosed with specific congenital heart defects, such as Tetralogy of Fallot or Atrioventricular Canal defects, and be admitted to the neonatal intensive care unit (NICU) at Montreal Children's Hospital. Babies who are born prematurely (before 34 weeks) or whose parents do not give consent will not be eligible. Throughout the study, parents will be informed about what to expect and can withdraw their consent at any time. This research aims to improve care for newborns with heart conditions and ensure they receive the best possible treatment.

Gender

ALL

Eligibility criteria

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 Parental consent can be withdrawn at any time during the study.

About Mcgill University Health Centre/Research Institute Of The Mcgill University Health Centre

The McGill University Health Centre (MUHC) and the Research Institute of the McGill University Health Centre (RI-MUHC) are leading institutions in clinical research and healthcare innovation. With a commitment to advancing medical knowledge and improving patient outcomes, the MUHC integrates cutting-edge research with high-quality patient care. The RI-MUHC fosters a collaborative environment where multidisciplinary teams engage in transformative research across various fields, including oncology, neurology, and cardiovascular health. By leveraging state-of-the-art facilities and a robust network of clinical expertise, both entities strive to translate scientific discoveries into effective treatments, ultimately enhancing the quality of life for patients locally and globally.

Locations

Montreal, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Gabriel Altit

Principal Investigator

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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