End-organ saturations correlate with aortic blood flow estimates by echocardiography in the extremely premature newborn - an observational cohort study.
Gabriel Altit, Shazia Bhombal, Valerie Y Chock
https://pubmed.ncbi.nlm.nih.gov/34253175Actively Recruiting
Age: 0Days - 7Days
All Genders
ID04106479
Near-infrared Spectroscopy and Echocardiographic Correlation in Newborns with Congenital Heart Defects
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2025-06-17
100
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on newborns with congenital heart defects (CHD), who face changes in blood flow and oxygen delivery during their first week of life. Researchers aim to compare near infrared spectroscopy (NIRS), a noninvasive method that measures oxygen levels in the brain and kidneys using skin stickers, with echocardiography, which uses ultrasound to assess heart function and blood flow. The study seeks to understand how well NIRS correlates with traditional echocardiographic measures in babies with CHD. The study involves placing NIRS probes on the newborn's forehead and abdomen to continuously monitor oxygen saturation in the brain and kidneys for up to seven days or until the baby is discharged or undergoes cardiac procedures. Daily echocardiography exams lasting 15 to 20 minutes will also be performed during this period. Newborns with CHD admitted to the neonatal intensive care unit (NICU) will be recruited either during fetal consultations or after birth. Participants will be closely monitored through continuous NIRS readings and daily echocardiography scans. Researchers will analyze correlations between cerebral and renal oxygen saturation and Doppler ultrasound measures of blood flow and heart performance throughout the first week of life. The study plans to enroll about 100 newborns to better understand how cardiac conditions affect oxygen delivery during this critical transitional period.
CONDITIONS
Brief Title
NIRS in Congenital Heart Defects - Correlation With Echocardiography
Who Can Participate
Age: 0Days - 7Days
All Genders
Eligibility Criteria
You may qualify if you...
- Newborns admitted to the neonatal intensive care unit (NICU) with congenital heart defects such as tetralogy of Fallot, truncus arteriosus, D-transposition of great arteries, pulmonary stenosis, aortic stenosis, coarctation of the aorta, double inlet left ventricle, atrioventricular canal, double outlet right ventricle, hypoplastic left heart syndrome, tricuspid atresia, and pulmonary atresia with intact ventricular septum
- Term infants monitored in the NICU with antenatal suspicion of coarctation that was ruled out after birth
- Born at or after 34 weeks of gestational age
- Up to 7 days old at enrollment
- Parental consent obtained
You will not qualify if you...
- Premature infants born before 34 weeks of gestational age
- Lack of parental consent or withdrawal of consent during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 7 days or until discharge, cardiac intervention, or surgery
Participants have a NIRS device attached to monitor brain and kidney oxygen saturation continuously. Daily echocardiography is performed to evaluate heart function and blood flow.
Daily echocardiography visits for up to 7 days
Trial Site Locations
Total: 1 location
1
Mcgill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
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Research Team
G
Gabriel Altit, MD
J
Jennifer Gardner
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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