Acute Maternal Hyperoxygenation for Fetal Transposition of the Great Arteries (TGA)
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|ClinicalTrials.gov Identifier: NCT03771534|
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : March 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|TGA - Transposition of Great Arteries||Drug: Oxygen gas||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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
- 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.
- 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)
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
|Contact: Edgar Jaeggi, MD||+1(416)813-7500 ext firstname.lastname@example.org|
|Contact: Mika Saito, MD||+1(416)813-7500 ext email@example.com|
|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|
|Principal Investigator:||Edgar Jaeggi, MD||The Hospital for Sick Children, Toronto|