Your session is about to expire
← Back to Search
Other
Maternal Hyperoxygenation for Congenital Heart Disease
N/A
Recruiting
Led By Mike Seed, MBBS
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
Pregnant mothers ≥18 years of age
Fetal diagnosis of specific congenital heart defects (CHDs) with intention of active treatment after birth
Timeline
Screening 3 weeks
Treatment Varies
Follow Up outcome measure obtained during hyperoxygenation while undergoing echocardiography and mri
Awards & highlights
Study Summary
This trial will study whether exposing fetuses with congenital heart disease to extra oxygen can improve their neurodevelopmental outcomes.
Who is the study for?
This trial is for pregnant mothers aged 18 or older with a fetus diagnosed with certain congenital heart defects (CHDs) and planning active post-birth treatment. It excludes those considering pregnancy termination, fetuses with unusual CHDs, major non-cardiac/genetic issues affecting brain development, complex cardiac conditions, significant maternal health problems that prevent MRI scans, or multiple pregnancies.Check my eligibility
What is being tested?
The study tests if breathing extra oxygen (maternal hyperoxygenation) can increase the unborn baby's brain oxygen levels in cases of CHD. The goal is to see if this could help the baby's brain grow better before birth and improve their learning abilities after they're born. It also seeks to find which types of CHD might benefit most from this treatment.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects of maternal hyperoxygenation may include dry throat or cough for the mother due to inhaling oxygen gas. However, these are generally mild and temporary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a pregnant woman aged 18 or older.
Select...
My unborn baby has been diagnosed with a heart defect and will receive treatment after birth.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ outcome measure obtained during hyperoxygenation while undergoing echocardiography and mri
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outcome measure obtained during hyperoxygenation while undergoing echocardiography and mri
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Characterize the hemodynamic effects of acute MH on fetuses with a) SV lesions and biventricular anomalies b) with TOF and c) with TGA.
Secondary outcome measures
Determine the pulmonary and placental vascular response to acute MH for each CHD
Other outcome measures
Assess the relationship between fetal brain volumes and cerebral oxygen delivery
To compare the prenatal measurement of placenta and the growth in body and brain size at birth.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Severe fetal congenital heart disease (CHD)Experimental Treatment1 Intervention
Mothers whose fetuses have a diagnosis of CHD will be exposed to 10-15 L/minute of oxygen while undergoing echocardiogaphy and MRI scanning
Find a Location
Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
689 Previous Clinical Trials
6,945,377 Total Patients Enrolled
Mike Seed, MBBSPrincipal InvestigatorThe Hospital for Sick Children
1 Previous Clinical Trials
40 Total Patients Enrolled
Edgar Jaeggi, MD, FRCP(C)Principal InvestigatorThe Hospital for Sick Children
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have certain complex heart defects, such as abnormal connections between the heart's chambers or obstructions in blood vessels.You have a serious heart problem, or the baby's heart is not working well.I am a pregnant woman aged 18 or older.My unborn baby has been diagnosed with a heart defect and will receive treatment after birth.The mother has health conditions that make it difficult to do a fetal MRI, like being very overweight or feeling very uncomfortable in small spaces.I do not have major brain development issues or genetic abnormalities.You are pregnant with more than one baby.
Research Study Groups:
This trial has the following groups:- Group 1: Severe fetal congenital heart disease (CHD)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are eligible for inclusion in this trial?
"Affirmative. According to the details online at clinicaltrials.gov, this medical trial is actively searching for participants with 170 individuals needed from one location. This study has been available since April 26th 2019 and was last modified on August 13th 2021."
Answered by AI
Is this research initiative currently open for participation?
"The relevant information found on clinicaltrials.gov shows that this trial is still recruiting participants, having been first listed on April 26th 2019 and recently updated on August 13 2021."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger