search
Back to results

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

Primary Purpose

TGA - Transposition of Great Arteries

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oxygen gas
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for TGA - Transposition of Great Arteries focused on measuring maternal hyperoxygenation, fetal echocardiography, fetal MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • The Hospital For Sick ChildrenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oxygen gas

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

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

Full Information

First Posted
October 11, 2018
Last Updated
April 8, 2021
Sponsor
The Hospital for Sick Children
search

1. Study Identification

Unique Protocol Identification Number
NCT03771534
Brief Title
Acute Maternal Hyperoxygenation for Fetal Transposition of the Great Arteries (TGA)
Official Title
Transposition of the Great Arteries: Prenatal Anatomical and Hemodynamic Findings Associated With Perinatal Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TGA - Transposition of Great Arteries
Keywords
maternal hyperoxygenation, fetal echocardiography, fetal MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxygen gas
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxygen gas
Other Intervention Name(s)
Praxair
Intervention Description
Brief maternal administration of 65-70% O2 via a face mask during the last trimester
Primary Outcome Measure Information:
Title
Fetal intracardiac/ductal shunting measured by echocardiogram flow patterns and MRI fluximetry
Description
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.
Time Frame
Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI
Title
Fetal pulmonary blood flow measured by MRI fluximetry
Description
Characterize effects of maternal hyperoxygenation on fetal pulmonary blood flow using MRI fluximetry (ml/min/m2) measures of Main PA, RPA and LPA
Time Frame
Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI
Title
Neonatal outcomes
Description
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.
Time Frame
Intrauterine demise to hospital discharge, or up to 1 year of age if pulmonary hypertension exists
Secondary Outcome Measure Information:
Title
Fetal cerebral perfusion
Description
Effects of maternal hyperoxygenation on fetal cerebral perfusion measured by change in cDO2 (mL/min/m2) and cVO2 (mL/min/m2)
Time Frame
Outcome measure obtained during maternal hyperoxygenation while undergoing echocardiography and MRI

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edgar Jaeggi, MD
Phone
+1(416)813-7500
Ext
207466
Email
edgar.jaeggi@sickkids.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mika Saito, MD
Phone
+1(416)813-7500
Ext
201527
Email
mika.saito@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgar Jaeggi, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital For Sick Children
City
Toronto
ZIP/Postal Code
M5G1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edgar Jaeggi, MD
First Name & Middle Initial & Last Name & Degree
Mika Saito, MD
First Name & Middle Initial & Last Name & Degree
Edgar Jaeggi, MD
First Name & Middle Initial & Last Name & Degree
Mike Seed, MD
First Name & Middle Initial & Last Name & Degree
Mika Saito, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29287129
Citation
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.
Results Reference
background
PubMed Identifier
26701792
Citation
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.
Results Reference
background
PubMed Identifier
25762062
Citation
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.
Results Reference
background
PubMed Identifier
24932863
Citation
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.
Results Reference
background
PubMed Identifier
24874055
Citation
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.
Results Reference
background
PubMed Identifier
29398177
Citation
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.
Results Reference
background
PubMed Identifier
27234352
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs