NIRS in Congenital Heart Defects – Correlation With Echocardiography

Brief Title

NIRS in Congenital Heart Defects - Correlation With Echocardiography

Official Title

Do Cerebral and Renal Saturations Measured With Near-infrared Spectroscopy Correlate With Echocardiographic Markers of Perfusion and Cardiac Performance in Congenital Heart Disease?

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.
    

Detailed Description

      Near infrared spectroscopy (NIRS) is a noninvasive technology that uses infrared light to
      measure Oxygen levels in tissue or organs. However, the use of this monitoring tool has not
      been the standard of care in the immediate post-natal life. The investigator wish to study
      this way of monitoring Oxygen, which consists of using a sticker on the skin of the forehead
      and the skin of the abdomen to continuously monitor the Oxygen content of the brain and the
      kidneys and compare NIRS values in the CHD population to echocardiographic measures of blood
      flow and heart function to see if/how this simple, non-invasive tool could help us to closely
      monitor Oxygen in babies with CHD.

      The NIRS probe (sticker) will be put on the side of the abdomen (the flank to monitor the
      kidney saturation of oxygen) and on the forehead (to monitor the brain saturation of oxygen)
      for 7 days or until the baby is discharged home, has a procedure in cath-lab or has surgery.
      An echocardiography will take place daily (for up to 7 days, or up to discharge, or up to
      cardiac intervention) during the day and should last about 15- 20 minutes. Newborns will be
      recruited during the fetal consultation with the cardiologist or neonatologist; or will be
      recruited during their neonatal admission. Only newborns admitted to the NICU will be
      eligible to the study.

      The investigator would like to better understand the way babies with cardiac conditions
      transition once they are born and into their first week of life. During that important time,
      there are a lot of changes that can impact the cardiac adaptation: vessels in the lungs that
      relax, vessels in the body that contract. Echocardiography and NIRS may help us better
      appreciate these changes by evaluating the delivery of oxygen to organs. Echocardiography may
      reveal some information about this adaptation by looking at the cardiac performance by
      ultrasound and blood flow patterns.

      Approximately 100 participants from this hospital will take part in this study.
    


Study Type

Observational


Primary Outcome

Correlation between cerebral saturation and ACA doppler

Secondary Outcome

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

Condition

Congenital Heart Defect

Intervention

NIRS evaluation


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

100

Start Date

October 11, 2019

Completion Date

August 1, 2023

Primary Completion Date

April 1, 2022

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.
      

Gender

All

Ages

N/A - 7 Days

Accepts Healthy Volunteers

No

Contacts

Gabriel Altit, 514-412-4452, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT04106479

Organization ID

2018-3823


Responsible Party

Principal Investigator

Study Sponsor

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

Collaborators

 Medtronic

Study Sponsor

Gabriel Altit, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre


Verification Date

June 2021