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

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Transposition of great arteries
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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