Oxygen boost for unborn babies with heart disease shows promise
NCT ID NCT03944837
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether giving extra oxygen to pregnant mothers carrying babies with congenital heart disease (CHD) could increase oxygen levels in the fetal brain. Researchers used ultrasound and MRI to measure changes in 53 fetuses with different types of CHD. The goal was to see if this approach might one day be used as a treatment to support brain growth before birth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- oxygen gas
- What this could lead to
- If successful, this could point toward a prenatal oxygen therapy to improve brain development in babies with congenital heart disease.
- What could go wrong
- This is a small, early-phase study (53 participants) that only measures short-term effects. It does not test long-term outcomes or safety of chronic oxygen use.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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53 people
The number who actually took part.
- Started
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Apr 2019
- Finished
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Dec 2023
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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 mothers ≥18 years of age * Written maternal informed consent * Fetal diagnosis of one of the CHDs (1-3) as listed below and intention of active treatment after birth: 1. Single ventricular (SV) lesions: hypoplastic left heart syndrome (HLHS); pulmonary atresia with intact ventricular septum (PA/IVS); tricuspid atresia (TA); unbalanced AV septal defect (AVSD); double inlet ventricle (DILV); and severe form of Ebstein's anomaly (EA) of the tricuspid valve associated with functional or anatomical right outflow obstruction. HLHS will include aortic stenosis with mitral stenosis, aortic atresia with mitral stenosis or mitral atresia. Pulmonary or aortic obstruction is defined as a condition with minimal or absent antegrade flow across the respective valve. Severe forms of EA is defined as lesion without anterograde pulmonary flow in the setting of severe tricuspid regurgitation. 2. Bi-ventricular lesions with right ventricular outflow tract obstruction (BV/RVOTO); tetralogy of Fallot (TOF), TOF-like double outlet right ventricle (DORV), and pulmonary atresia with ventricular septal defect (PA/VSD). 3. Bi-ventricular lesions with transposed great arteries (TGA w/ VSD; TGA w/o VSD; DORV with TGA) Exclusion Criteria: * Termination of pregnancy * Unusual CHDs (e.g. EA with circular shunt, TOF with AVSD, and TOF with absent pulmonary valve syndrome, TGA associated with moderate- severe outflow tract obstruction * Complex cardiac condition (e.g poor fetal cardiac function and/or fetal hydrops, fetal arrhythmia such as frequent premature atrial beats, abnormal baseline heart rate (\<110 bpm; \> 160 bpm) in the third trimester) * Major non-cardiac lesions and major genetic abnormalities affecting brain size and development * Significant maternal co-morbidities that precludes a fetal MRI (e.g. significant obesity, claustrophobia) * Multiple pregnancy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Hospital for Sick Children
Toronto, Ontario, M5G1X8, Canada
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