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

Must not have

Major non-cardiac lesions and major genetic abnormalities affecting brain size and development

Timeline

Screening 3 weeks

Treatment Varies

Follow Up outcome measure obtained during hyperoxygenation while undergoing echocardiography and mri

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am a pregnant woman aged 18 or older.

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My unborn baby has been diagnosed with a heart defect and will receive treatment after birth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have major brain development issues or genetic abnormalities.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and outcome measure obtained during hyperoxygenation while undergoing echocardiography and mri for reporting.