NIRS in Congenital Heart Defects - Correlation With Echocardiography

Tetralogy of Fallot Clinical Trial

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04106479
• Other study ID #: 2018-3823
• Status: Recruiting
• Start date: October 11, 2019
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Gabriel Altit, MD
• Phone: 514-412-4452
• Email: gabriel.altit[@]mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2024
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 7 Days

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Atresia
• Aortic Coarctation
• Atrioventricular Canal
• Coarctation of Aorta
• Congenital Heart Defect
• Heart Defects, Congenital
• Hypoplastic Left Heart
• Hypoplastic Left Heart Syndrome
• Interrupted Aortic Arch
• Pulmonary Atresia
• Single-ventricle
• Tetralogy of Fallot
• Transposition of Great Vessels
• Tricuspid Atresia
• Univentricular Heart

Intervention

Device:
• NIRS evaluation
NIRS will be used for measurement of cerebral and renal saturation.

Locations

Country	Name	City	State
Canada	Mcgill University Health Centre	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Medtronic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between cerebral saturation and ACA doppler		Measures from Day 0 to Day7
Primary	Correlation between aortic doppler and renal NIRS measures		Measures from Day 0 to Day7
Secondary	Correlation between LV performance by STE and Csat and Rsat by NIRs		Measures from Day 0 to Day7