RecruitingNot Applicable

NIRS in Congenital Heart Defects - Correlation With Echocardiography

Canada100 participantsStarted 2019-10-11

Plain-language 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.

Who can participate

Age range

0 Days – 7 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Parental consent can be withdrawn at any time during the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Correlation between cerebral saturation and ACA doppler

Timeframe: Measures from Day 0 to Day7

Correlation between aortic doppler and renal NIRS measures

Timeframe: Measures from Day 0 to Day7

Trial details

NCT IDNCT04106479

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

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-04-01

Contact for this trial

Gabriel Altit, MD

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

View on ClinicalTrials.gov More Congenital Heart Defect trials