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TGA - Transposition of Great ArteriesNCT03771534

Acute Maternal Hyperoxygenation for Fetal Transposition of the Great Arteries (TGA)

A study testing Oxygen gas in people with TGA - Transposition of Great Arteries, run by The Hospital for Sick Children at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective study will examine whether transient maternal hyperoxygenation is useful as a diagnostic test to more accurately detect TGA patients with poor vs. good neonatal intra-cardiac mixing of blood, based on the in-utero response to oxygen exposure. This study is Health Canada regulated Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
TGA - Transposition of Great Arteries
What is being tested?
Oxygen gas
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteCanada
Study dates
20 Sep 2018to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fetus with simple TGA +/- small VSD
  • Intention of active postnatal management after birth

Who cannot join

  • Fetus with complex form of TGA
  • Significant fetal arrhythmia
  • Major non-cardiac lesions
  • Maternal contraindications for fetal MRI

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Hospital For Sick Children

    Toronto, M5G1X8

Other trials in Canada

About this study

Official title: Transposition of the Great Arteries: Prenatal Anatomical and Hemodynamic Findings Associated With Perinatal Outcomes

This prospective study will examine whether transient maternal hyperoxygenation is useful as a diagnostic test to more accurately detect TGA patients with poor vs. good neonatal intra-cardiac mixing of blood, based on the in-utero response to oxygen exposure. This study is Health Canada regulated

Read the detailed description

This is a prospective pilot study to examine whether transient maternal hyperoxygenation is useful as a diagnostic test to more accurately detect TGA patients with poor vs. good neonatal intracardiac mixing of blood, based on the in-utero response to oxygen exposure. Acute maternal oxygen administration will transiently increase the fetal oxygen levels to those reached at birth with spontaneous breathing, thus simulating conditions that will naturally occur at the time of birth. Echocardiogram and MRI will be used to examine the effects on the fetal circulation. The prenatal findings will then be compared to the neonatal presentation.

The investigators postulate that conditions that predispose newborns to acute neonatal compromise will be detectable and distinguishable prior to birth by echocardiography, MRI, or by combining the findings of both exams.

Being tested
Oxygen gas
Keywords
maternal hyperoxygenation, fetal echocardiography, fetal MRI
Medical subject headings
Transposition of Great Vessels

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxygen gasDrug

    Also called Praxair

    Brief maternal administration of 65-70% O2 via a face mask during the last trimester

Study groups in NCT03771534
Study groupRoleWhat they receive
Oxygen gasExperimental10-15 L/min of oxygen by face mask for up to 45 minutes for the MRI and up to 30 minutes for the echocardiogram.
Receives: Drug: Oxygen gas

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fetal intracardiac/ductal shunting measured by echocardiogram flow patterns and MRI fluximetry

    Characterize effects of maternal hyperoxygenation on fetal intracardiac shunting measured using MRI fluximetry (ml/min/m2) of AAo, DA, SVC, IVC, UV, and DA.

    Ductal shunting measured using echo measurements of atrial septal morphology (2D; 4D) and foramen flow (color; 4D flow) of FO diameter and septal excursion. Ductus arteriosus flow (color and Doppler): minimal diameter, reversed end-diastolic flow, systolic peak flow, forward-reverse flow ratio, flow restriction.

    Measured: Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI

  2. Fetal pulmonary blood flow measured by MRI fluximetry

    Characterize effects of maternal hyperoxygenation on fetal pulmonary blood flow using MRI fluximetry (ml/min/m2) measures of Main PA, RPA and LPA

    Measured: Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI

  3. Neonatal outcomes

    As measure of patient morbidity, a composite score of 10 variables will be used, assigning a value of 1 for each event that occurred 1) respiratory distress syndrome requiring surfactant; 2) cardiopulmonary resuscitation requiring chest compressions; 3) cerebral vascular injury (intra-ventricular or -parenchymal hemorrhage, ischemic stroke); 4) necrotizing enterocolitis; 5) need of ECMO; 6) infections associated with health care (bloodstream, surgical site, and urinary tract infection); 7) unplanned re-intubation; 8) re-operation for residual cardiac lesions; 9) interventional catheterization for residual cardiac lesions; and 10) unplanned intensive care readmission.

    Measured: Intrauterine demise to hospital discharge, or up to 1 year of age if pulmonary hypertension exists

Secondary outcomes (1)

  1. Fetal cerebral perfusion

    Effects of maternal hyperoxygenation on fetal cerebral perfusion measured by change in cDO2 (mL/min/m2) and cVO2 (mL/min/m2)

    Measured: Outcome measure obtained during maternal hyperoxygenation while undergoing echocardiography and MRI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2018
  2. Study start20 Sep 2018
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03771534
Sponsor's protocol ID
1000060514
Status last verified
Apr 2026
First submitted
11 Oct 2018
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sun L, Macgowan CK, Portnoy S, Sled JG, Yoo SJ, Grosse-Wortmann L, Jaeggi E, Kingdom J, Seed M. New advances in fetal cardiovascular magnetic resonance imaging for quantifying the distribution of blood flow and oxygen transport: Potential applications in fetal cardiovascular disease diagnosis and therapy. Echocardiography. 2017 Dec;34(12):1799-1803. doi: 10.1111/echo.13760.

    PubMed 29287129

  • Porayette P, Madathil S, Sun L, Jaeggi E, Grosse-Wortmann L, Yoo SJ, Hickey E, Miller SP, Macgowan CK, Seed M. MRI reveals hemodynamic changes with acute maternal hyperoxygenation in human fetuses with and without congenital heart disease. Prenat Diagn. 2016 Mar;36(3):274-81. doi: 10.1002/pd.4762. Epub 2016 Feb 9.

    PubMed 26701792

  • Sun L, Macgowan CK, Sled JG, Yoo SJ, Manlhiot C, Porayette P, Grosse-Wortmann L, Jaeggi E, McCrindle BW, Kingdom J, Hickey E, Miller S, Seed M. Reduced fetal cerebral oxygen consumption is associated with smaller brain size in fetuses with congenital heart disease. Circulation. 2015 Apr 14;131(15):1313-23. doi: 10.1161/CIRCULATIONAHA.114.013051. Epub 2015 Mar 11.

    PubMed 25762062

  • Porayette P, van Amerom JF, Yoo SJ, Jaeggi E, Macgowan CK, Seed M. MRI shows limited mixing between systemic and pulmonary circulations in foetal transposition of the great arteries: a potential cause of in utero pulmonary vascular disease. Cardiol Young. 2015 Apr;25(4):737-44. doi: 10.1017/S1047951114000870. Epub 2014 Jun 16.

    PubMed 24932863

  • Prsa M, Sun L, van Amerom J, Yoo SJ, Grosse-Wortmann L, Jaeggi E, Macgowan C, Seed M. Reference ranges of blood flow in the major vessels of the normal human fetal circulation at term by phase-contrast magnetic resonance imaging. Circ Cardiovasc Imaging. 2014 Jul;7(4):663-70. doi: 10.1161/CIRCIMAGING.113.001859. Epub 2014 May 29.

    PubMed 24874055

  • Mawad W, Chaturvedi RR, Ryan G, Jaeggi E. Percutaneous Fetal Atrial Balloon Septoplasty for Simple Transposition of the Great Arteries With an Intact Atrial Septum. Can J Cardiol. 2018 Mar;34(3):342.e9-342.e11. doi: 10.1016/j.cjca.2017.12.010. Epub 2017 Dec 15.

    PubMed 29398177

  • Jaeggi E, Renaud C, Ryan G, Chaturvedi R. Intrauterine therapy for structural congenital heart disease: Contemporary results and Canadian experience. Trends Cardiovasc Med. 2016 Oct;26(7):639-46. doi: 10.1016/j.tcm.2016.04.006. Epub 2016 Apr 22.

    PubMed 27234352

Questions about this trial

What is this clinical trial studying?

A study testing Oxygen gas in people with TGA - Transposition of Great Arteries, run by The Hospital for Sick Children at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fetal intracardiac/ductal shunting measured by echocardiogram flow patterns and MRI fluximetry (time frame: Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03771534, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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