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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03771534
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Edgar Jaeggi, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
TGA - Transposition of Great Arteries Drug: Oxygen gas Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Transposition of the Great Arteries: Prenatal Anatomical and Hemodynamic Findings Associated With Perinatal Outcomes
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021


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 Name: Praxair




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771534


Contacts
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Contact: Edgar Jaeggi, MD +1(416)813-7500 ext 207466 edgar.jaeggi@sickkids.ca
Contact: Mika Saito, MD +1(416)813-7500 ext 201527 mika.saito@sickkids.ca

Locations
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Canada
The Hospital For Sick Children Recruiting
Toronto, Canada, M5G1X8
Contact: Edgar Jaeggi, MD         
Contact: Mika Saito, MD         
Principal Investigator: Edgar Jaeggi, MD         
Sub-Investigator: Mike Seed, MD         
Sub-Investigator: Mika Saito, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Edgar Jaeggi, MD The Hospital for Sick Children, Toronto
  Study Documents (Full-Text)

Documents provided by Edgar Jaeggi, The Hospital for Sick Children:
Informed Consent Form  [PDF] November 7, 2018

Publications:

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Responsible Party: Edgar Jaeggi, Principal Investigator, Head of Fetal Cardiology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03771534    
Other Study ID Numbers: 1000060514
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Edgar Jaeggi, The Hospital for Sick Children:
maternal hyperoxygenation
fetal echocardiography
fetal MRI
Additional relevant MeSH terms:
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Transposition of Great Vessels
Situs Inversus
Congenital Abnormalities
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases