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