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

The Hospital for Sick Children

Status: Enrolling

Conditions: TGA - Transposition of Great Arteries

Treatments: Drug: Oxygen gas

Study type: Interventional

Funder types: Other

Identifiers

NCT03771534

1000060514

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Oxygen gas

Experimental group

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.

Treatment:

Drug: Oxygen gas