NCT04106479 NIRS in Congenital Heart Defects - Correlation With Echocardiography
| NCT ID | NCT04106479 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | Congenital Heart Defect |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2019-10-11 |
| Primary Completion | 2023-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2019-10-11 with a primary completion date of 2023-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 Parental consent can be withdrawn at any time during the study.
Contact & Investigator
Gabriel Altit
PRINCIPAL INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Frequently Asked Questions
Who can join the NCT04106479 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 7 Days, studying Congenital Heart Defect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04106479 currently recruiting?
Yes, NCT04106479 is actively recruiting participants. Contact the research team at gabriel.altit@mcgill.ca for enrollment information.
Where is the NCT04106479 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT04106479 clinical trial?
NCT04106479 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The principal investigator is Gabriel Altit at McGill University Health Centre/Research Institute of the McGill University Health Centre. The trial plans to enroll 100 participants.