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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03771534

Enrollment

Registered

2018-12-11

Start date

2018-09-20

Completion date

2023-12-31

Last updated

2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TGA - Transposition of Great Arteries

Keywords

maternal hyperoxygenation, fetal echocardiography, fetal MRI

Brief 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

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.

Interventions

DRUGOxygen gas

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Fetal intracardiac/ductal shunting measured by echocardiogram flow patterns and MRI fluximetry	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.
Fetal pulmonary blood flow measured by MRI fluximetry	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
Neonatal outcomes	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

Measure	Time frame	Description
Fetal cerebral perfusion	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)

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATOREdgar Jaeggi, MD

The Hospital for Sick Children, Toronto

PRINCIPAL_INVESTIGATORMike Seed, MBBS