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

Related Clinical Trial
Clinical Impact of Rapid Prototyping 3D Models for Surgical Management A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels Comprehensive Long-term Follow up of Adults With Arterial Switch Operation Erythropoetin Neuroprotection for Neonatal Cardiac Surgery Initiation of Resuscitation While Attached to the Cord With Congenital Heart Disease Canadian Adult Congenital Heart Disease Intervention Registry Physical Training in Transposition of the Great Arteries Eplerenone in Systemic Right Ventricle N-Acetylcysteine in Neonatal Congenital Heart Surgery (INACT Study) Genetic Determinants of Congenital Heart Disease Outcomes Myocardial Contrast Echocardiography in Congenital Heart Disease Sudden Cardiac Death in Systemic Right Ventricle Haemodynamics and Function of the Atria in Congenital Heart Disease by Cardiovascular Magnetic Resonance The Boston Circulatory Arrest Study: Antecedents and Correlates of Well-Being in Adults With Congenital Heart Disease Comparison of Hematocrit Levels in Infant Heart Surgery Late Function After Surgery for Transposition of the Great Arteries Acute Maternal Hyperoxygenation for Fetal Transposition of the Great Arteries (TGA) MRI Study After Arterial Switch Operation in Patients With Transposition of the Great Arteries Fibrosis, Valvular and Ventricular Function in Patients With TGA Characterization of the Cardiac Reinnervation of Patients With Transposition of the Great Arteries Long After Repair With the Arterial Switch Operation. Correlation With Electrocardiographic and Exercise Test Parameters Cardiovascular MRI and Cardiopulmonary Exercise Capacity After Neonatal ASO) in Young Adults Nitric Oxide During Bypass for Arterial Switch Operation

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

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.
    


Study Type

Interventional


Primary Outcome

Fetal intracardiac/ductal shunting measured by echocardiogram flow patterns and MRI fluximetry

Secondary Outcome

 Fetal cerebral perfusion

Condition

TGA - Transposition of Great Arteries

Intervention

Oxygen gas

Study Arms / Comparison Groups

 Oxygen gas
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

September 20, 2018

Completion Date

March 31, 2022

Primary Completion Date

March 31, 2022

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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Edgar Jaeggi, MD, +1(416)813-7500, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT03771534

Organization ID

1000060514


Responsible Party

Principal Investigator

Study Sponsor

The Hospital for Sick Children


Study Sponsor

Edgar Jaeggi, MD, Principal Investigator, The Hospital for Sick Children, Toronto


Verification Date

April 2021