CompletedPhase 1/2

Maternal Hyperoxygenation in Congenital Heart Disease

Canada25 participantsStarted 2018-02-02

Plain-language summary

A pilot study investigating the safety and feasibility of chronic maternal hyperoxygenation in the setting of fetal congenital heart disease

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Between 20-32 weeks gestation * Diagnosis of fetus with a single ventricular ventricular heart * Delivering at Mount Sinai Hospital * Written informed consent Exclusion Criteria: * Opting for termination of pregnancy/ comfort care * Normal exclusions for MRI (e.g. claustrophobia, cardiac pacemaker, etc.) * BMI \>37.0 * Infections/ anemia * Smoker * Serious cardiorespiratory co-morbidities

What they're measuring

The general condition of the child and mother at the time of birth

Timeframe: 2 years

The duration of oxygen therapy tolerated by the subjects

Timeframe: 2 years

Trial details

NCT IDNCT03136835

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-22

View on ClinicalTrials.gov More Hypoplastic Left Heart Syndrome trials