Acute Maternal Hyperoxygenation in CHD

NCT03944837 | Completed DMC

• 1 other identifier: 1000062939
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Congenital heart disease (CHD) is predominantly detected before birth. Using echocardiography and MRI, this study will determine whether acute exposure to maternal hyperoxygenation (MH) leads to measurable increases in fetal cerebral oxygenation from baseline in fetuses with CHD. The study aims to determine whether MH could be used as a chronic in-utero treatment strategy to promote brain growth/maturation to birth and to improve postnatal neurodevelopmental outcomes, and identify the types of CHD most likely to benefit from chronic MH.

Conditions

Congenital Heart Disease

Keywords

Acute maternal hyperoxygenation; Echocardiography; MRI

Outcome Measures

Primary Outcomes (1)

• Characterize the hemodynamic effects of acute MH on fetuses with a) SV lesions and biventricular anomalies b) with TOF and c) with TGA.

  The affect MH has on the cerebral oxygenation from baseline for each type of CHD will be characterized using the MRI variables of cerebral oxygen delivery (cDO2) and cerebral oxygen consumption(cVO2) , which are calculated using fluximetry measurements (ml/min/m2) and the oxymetry of the ascending aorta and the superior vena cava

  Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI

Secondary Outcomes (1)

• Determine the pulmonary and placental vascular response to acute MH for each CHD

  Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI

Other Outcomes (2)

• Assess the relationship between fetal brain volumes and cerebral oxygen delivery

  Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI

• To compare the prenatal measurement of placenta and the growth in body and brain size at birth.

  Date of echocardiography/MRI to the date of the infant's birth, when the birth weight, height and head circumference data become available.

Study Arms (1)

Severe fetal congenital heart disease (CHD)

EXPERIMENTAL

Mothers whose fetuses have a diagnosis of CHD will be exposed to 10-15 L/minute of oxygen while undergoing echocardiogaphy and MRI scanning

Other: Oxygen gas

Interventions

Oxygen gas OTHER

Transient maternal oxygen administration during echocardiographic and MRI imaging

Severe fetal congenital heart disease (CHD)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant mothers ≥18 years of age
• Written maternal informed consent
• Fetal diagnosis of one of the CHDs (1-3) as listed below and intention of active treatment after birth:
• Single ventricular (SV) lesions: hypoplastic left heart syndrome (HLHS); pulmonary atresia with intact ventricular septum (PA/IVS); tricuspid atresia (TA); unbalanced AV septal defect (AVSD); double inlet ventricle (DILV); and severe form of Ebstein's anomaly (EA) of the tricuspid valve associated with functional or anatomical right outflow obstruction. HLHS will include aortic stenosis with mitral stenosis, aortic atresia with mitral stenosis or mitral atresia. Pulmonary or aortic obstruction is defined as a condition with minimal or absent antegrade flow across the respective valve. Severe forms of EA is defined as lesion without anterograde pulmonary flow in the setting of severe tricuspid regurgitation.
• Bi-ventricular lesions with right ventricular outflow tract obstruction (BV/RVOTO); tetralogy of Fallot (TOF), TOF-like double outlet right ventricle (DORV), and pulmonary atresia with ventricular septal defect (PA/VSD).
• Bi-ventricular lesions with transposed great arteries (TGA w/ VSD; TGA w/o VSD; DORV with TGA)

You may not qualify if:

• Termination of pregnancy
• Unusual CHDs (e.g. EA with circular shunt, TOF with AVSD, and TOF with absent pulmonary valve syndrome, TGA associated with moderate- severe outflow tract obstruction
• Complex cardiac condition (e.g poor fetal cardiac function and/or fetal hydrops, fetal arrhythmia such as frequent premature atrial beats, abnormal baseline heart rate (\<110 bpm; \> 160 bpm) in the third trimester)
• Major non-cardiac lesions and major genetic abnormalities affecting brain size and development
• Significant maternal co-morbidities that precludes a fetal MRI (e.g. significant obesity, claustrophobia)
• Multiple pregnancy

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

nitrox

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Edgar Jaeggi, MD, FRCP(C)

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Mike Seed, MBBS

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 10, 2019
• Study Start: April 26, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)