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Oxygen Therapy for Fetal Heart Defects
N/A
Recruiting
Led By Edgar Jaeggi, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Fetus with simple TGA +/- small VSD
Be older than 18 years old
Must not have
Major non-cardiac lesions
Fetus with complex form of TGA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intrauterine demise to hospital discharge, or up to 1 year of age if pulmonary hypertension exists
Awards & highlights
No Placebo-Only Group
Summary
This trial will investigate if giving extra oxygen to pregnant women can help doctors better detect babies with heart defects before they are born. The study is regulated by Health Canada.
Who is the study for?
This trial is for pregnant individuals whose fetus has been diagnosed with a heart condition known as Transposition of the Great Arteries (TGA), with or without a small hole in the heart (VSD). Participants should be planning on active management after the baby's birth.
What is being tested?
The study is testing if breathing extra oxygen (hyperoxygenation) can help doctors better predict which babies with TGA will have good or poor mixing of blood in their hearts before they are born.
What are the potential side effects?
Breathing extra oxygen generally has minimal side effects, but potential risks include dryness of the nasal passages and mild discomfort from wearing an oxygen mask.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My unborn baby has been diagnosed with a heart condition involving the transposition of the great arteries, possibly with a small hole in the heart.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have significant health issues not related to my heart.
Select...
My unborn baby has a complex heart condition called TGA.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intrauterine demise to hospital discharge, or up to 1 year of age if pulmonary hypertension exists
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intrauterine demise to hospital discharge, or up to 1 year of age if pulmonary hypertension exists
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fetal intracardiac/ductal shunting measured by echocardiogram flow patterns and MRI fluximetry
Fetal pulmonary blood flow measured by MRI fluximetry
Neonatal outcomes
Secondary study objectives
Fetal cerebral perfusion
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Oxygen gasExperimental Treatment1 Intervention
10-15 L/min of oxygen by face mask for up to 45 minutes for the MRI and up to 30 minutes for the echocardiogram.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxygen gas
2021
Completed Phase 3
~11330
Find a Location
Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
712 Previous Clinical Trials
6,959,759 Total Patients Enrolled
Edgar Jaeggi, MDPrincipal InvestigatorThe Hospital for Sick Children, Toronto
2 Previous Clinical Trials
455 Total Patients Enrolled
Mike Seed, MBBSPrincipal InvestigatorThe Hospital for Sick Children, Toronto
1 Previous Clinical Trials
60 Total Patients Enrolled