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

NCT03771534 | Completed DMC

• 1 other identifier: 1000060514
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

TGA - Transposition of Great Arteries

Keywords

maternal hyperoxygenation; fetal echocardiography; fetal MRI

Outcome Measures

Primary Outcomes (3)

• 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.

  Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI

• 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

  Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI

• 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.

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

Secondary Outcomes (1)

• Fetal cerebral perfusion

  Outcome measure obtained during maternal hyperoxygenation while undergoing echocardiography and MRI

Study Arms (1)

Oxygen gas

EXPERIMENTAL

10-15 L/min of oxygen by face mask for up to 45 minutes for the MRI and up to 30 minutes for the echocardiogram.

Drug: Oxygen gas

Interventions

Oxygen gas DRUG

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

Also known as: Praxair

Oxygen gas

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital For Sick Children

Toronto, M5G1X8, Canada

Location

Related Publications (7)

• 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.

  PMID: 29287129 BACKGROUND

• 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.

  PMID: 26701792 BACKGROUND

• 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.

  PMID: 25762062 BACKGROUND

• 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.

  PMID: 24932863 BACKGROUND

• 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.

  PMID: 24874055 BACKGROUND

• 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.

  PMID: 29398177 BACKGROUND

• 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.

  PMID: 27234352 BACKGROUND

MeSH Terms

Conditions

Transposition of Great Vessels

Interventions

nitrox

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Edgar Jaeggi, MD

  The Hospital for Sick Children, Toronto

  PRINCIPAL INVESTIGATOR

• Mike Seed, MBBS

  The Hospital for Sick Children, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: December 11, 2018
• Study Start: September 20, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)