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Oxygen test during pregnancy may predict brain development in Heart-Defect babies

NCT ID NCT05767385

Knowledge-focused Sponsor: University of Utah Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study looks at how blood flow to the fetal brain is affected in babies with congenital heart disease and whether it relates to their development after birth. Pregnant women with a fetus known or suspected to have a heart defect will have a fetal echocardiogram, then breathe extra oxygen for 10 minutes to see how the brain's blood vessels respond. After birth, babies will take a neurobehavioral test to link brain blood flow patterns with developmental outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
maternal hyperoxia (8 liters of 100% oxygen via face mask for 10 minutes)
What this could lead to
If successful, this could help identify babies at risk for developmental delays before birth, allowing early intervention.
What could go wrong
This is an observational study with a small intervention, so it cannot prove cause and effect. Results may not apply to all types of congenital heart disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

104 people

The number who actually took part.

Started

Dec 2021

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 52 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pregnant women 18 years of age and over with a singleton fetus with known or suspected congenital heart disease anticipated to need intervention or surgery within 30 days of birth. Exclusion Criteria: * Known fetal chromosomal or genetic abnormalities * Multiple gestation pregnancy * Fetal extra-cardiac anomalies

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Conditions

The condition(s) this trial relates to.

congenital heart disease Hypoxia neurodevelopmental disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Complex congenital heart disease Congenital heart disease in children Hypoxia Neurodevelopmental disorders

Contacts and locations

Locations

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010, United States

  • Maine Medical Center

    Scarborough, Maine, 04074, United States

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

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