- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03136835
Maternal Hyperoxygenation in Congenital Heart Disease (MATCH)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Mike Seed, MD
- Phone Number: 202459 416-813-7654
- Email: mike.seed@sickkids.ca
Study Contact Backup
- Name: Natasha Milligan, BSc
- Phone Number: 6419 416-586-4800
- Email: natasha.milligan@sickkids.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pilot
Maternal Hyperoxygenation (4L/min via nasal prongs)
|
Oxygen via nasal prongs at up to 4L/min continuously during 2nd and 3rd trimester of pregnancy until birth
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The general condition of the child and mother at the time of birth
Time Frame: 2 years
|
The general condition of the child and mother at birth, classified by any maternal or fetal adverse events.
Adverse events will also be classified as mild, moderate, severe, life-threatening or disabling, or fatal.
The investigators will further define adverse events in terms of their effect on usual daily activities as follows: mild (an awareness of symptoms but easily tolerated), moderate (symptoms interfere with normal daily activities) or severe (symptoms are incapacitating, with the inability to perform daily activities).
As unexpected adverse effects are by definition difficult to predict, the investigators use a variety of sources of information to identify possible side effects of the treatment including participant diaries, direct observations, participant reports, laboratory reports and other medical reports.
|
2 years
|
The duration of oxygen therapy tolerated by the subjects
Time Frame: 2 years
|
This will be as a proportion of the maximum potential duration if the subjects had adhered to the continuous therapy from enrollment to birth. If the treatment is not tolerable by a substantial number (e.g. >10%) of subjects for significant periods of time (e.g. more than 8 hours a day) in the pilot study then this will be considered a negative result, i.e. that the treatment is not feasible. |
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mike Seed, MD, The Hospital for Sick Children
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000048468
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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