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NCT Number: NCT03771534

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

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

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Key information

Conditions

TGA - Transposition of Great Arteries Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Transposition of Great Vessels

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital For Sick Children

Toronto, M5G1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Oxygen gas

Drug

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

Other names: Praxair

Primary outcomes

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

    Time frame: Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI

    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.

  2. Fetal pulmonary blood flow measured by MRI fluximetry

    Time frame: Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI

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

  3. Neonatal outcomes

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

    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.

Secondary outcomes

  1. Fetal cerebral perfusion

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

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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Dec 11, 2018
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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