Clinical trial NCT03771534: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: TGA - Transposition of Great Arteries
Keywords: maternal hyperoxygenation
fetal echocardiography
fetal MRI
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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. This study is Health Canada regulated

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.

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

Primary outcomes:
measure: Fetal intracardiac/ductal shunting measured by echocardiogram flow patterns and MRI fluximetry
timeFrame: Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI
measure: Fetal pulmonary blood flow measured by MRI fluximetry
timeFrame: Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI
measure: Neonatal outcomes
timeFrame: Intrauterine demise to hospital discharge, or up to 1 year of age if pulmonary hypertension exists
Secondary outcomes:
measure: Fetal cerebral perfusion
timeFrame: Outcome measure obtained during maternal hyperoxygenation while undergoing echocardiography and MRI
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital For Sick Children
Study officials:
affiliation: The Hospital for Sick Children, Toronto
name: Edgar Jaeggi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children, Toronto
name: Mike Seed, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun L, Macgowan CK, Portnoy S, Sled JG, Yoo SJ, Grosse-Wortmann L, Jaeggi E, Kingdom J, Seed M. New advances in fetal cardiovascular magnetic resonance imaging for quantifying the distribution of blood flow and oxygen transport: Potential applications in fetal cardiovascular disease diagnosis and therapy. Echocardiography. 2017 Dec;34(12):1799-1803. doi: 10.1111/echo.13760.
citation: Porayette P, Madathil S, Sun L, Jaeggi E, Grosse-Wortmann L, Yoo SJ, Hickey E, Miller SP, Macgowan CK, Seed M. MRI reveals hemodynamic changes with acute maternal hyperoxygenation in human fetuses with and without congenital heart disease. Prenat Diagn. 2016 Mar;36(3):274-81. doi: 10.1002/pd.4762. Epub 2016 Feb 9.
citation: Sun L, Macgowan CK, Sled JG, Yoo SJ, Manlhiot C, Porayette P, Grosse-Wortmann L, Jaeggi E, McCrindle BW, Kingdom J, Hickey E, Miller S, Seed M. Reduced fetal cerebral oxygen consumption is associated with smaller brain size in fetuses with congenital heart disease. Circulation. 2015 Apr 14;131(15):1313-23. doi: 10.1161/CIRCULATIONAHA.114.013051. Epub 2015 Mar 11.
citation: Porayette P, van Amerom JF, Yoo SJ, Jaeggi E, Macgowan CK, Seed M. MRI shows limited mixing between systemic and pulmonary circulations in foetal transposition of the great arteries: a potential cause of in utero pulmonary vascular disease. Cardiol Young. 2015 Apr;25(4):737-44. doi: 10.1017/S1047951114000870. Epub 2014 Jun 16.
citation: Prsa M, Sun L, van Amerom J, Yoo SJ, Grosse-Wortmann L, Jaeggi E, Macgowan C, Seed M. Reference ranges of blood flow in the major vessels of the normal human fetal circulation at term by phase-contrast magnetic resonance imaging. Circ Cardiovasc Imaging. 2014 Jul;7(4):663-70. doi: 10.1161/CIRCIMAGING.113.001859. Epub 2014 May 29.
citation: Mawad W, Chaturvedi RR, Ryan G, Jaeggi E. Percutaneous Fetal Atrial Balloon Septoplasty for Simple Transposition of the Great Arteries With an Intact Atrial Septum. Can J Cardiol. 2018 Mar;34(3):342.e9-342.e11. doi: 10.1016/j.cjca.2017.12.010. Epub 2017 Dec 15.
citation: Jaeggi E, Renaud C, Ryan G, Chaturvedi R. Intrauterine therapy for structural congenital heart disease: Contemporary results and Canadian experience. Trends Cardiovasc Med. 2016 Oct;26(7):639-46. doi: 10.1016/j.tcm.2016.04.006. Epub 2016 Apr 22.