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Oxygen gas for Transposition of the Great Arteries

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
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

Study 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.Check my eligibility
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.See study design
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 below
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intrauterine demise to hospital discharge, or up to 1 year of age if pulmonary hypertension exists
This trial's timeline: 3 weeks for screening, Varies for treatment, and intrauterine demise to hospital discharge, or up to 1 year of age if pulmonary hypertension exists for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fetal intracardiac/ductal shunting measured by echocardiogram flow patterns and MRI fluximetry
Fetal pulmonary blood flow measured by MRI fluximetry
Neonatal outcomes
Secondary outcome measures
Fetal cerebral perfusion

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
690 Previous Clinical Trials
6,945,438 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Acute Maternal Hyperoxygenation for Fetal Transposition of the Great Arteries (TGA)
Edgar Jaeggi 2018. "Acute Maternal Hyperoxygenation for Fetal Transposition of the Great Arteries (TGA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03771534.
~2 spots leftby Aug 2024
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