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

January 29, 2024 updated by: Edgar Jaeggi, The Hospital for Sick Children

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
      • Toronto, Canada, M5G1X8
        • Recruiting
        • The Hospital for Sick Children
        • Contact:
          • Edgar Jaeggi, MD
        • Contact:
          • Mike Seed, MBBS
        • Principal Investigator:
          • Edgar Jaeggi, MD
        • Principal Investigator:
          • Mike Seed, MBBS
        • Sub-Investigator:
          • Liqun Sun, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxygen gas
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
Brief maternal administration of 65-70% O2 via a face mask during the last trimester
Other Names:
  • Praxair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI
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
Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI
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.
Intrauterine demise to hospital discharge, or up to 1 year of age if pulmonary hypertension exists

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Outcome measure obtained during maternal hyperoxygenation while undergoing echocardiography and MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Edgar Jaeggi, MD, The Hospital for Sick Children, Toronto
  • Principal Investigator: Mike Seed, MBBS, The Hospital for Sick Children, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2018

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

December 7, 2018

First Posted (Actual)

December 11, 2018

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000060514

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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