CompletedNot Applicable

Acute Maternal Hyperoxygenation in CHD

Canada53 participantsStarted 2019-04-26

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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)

What they're measuring

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

Timeframe: Outcome measure obtained during hyperoxygenation while undergoing echocardiography and MRI

Trial details

NCT IDNCT03944837

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Congenital Heart Disease trials