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Maternal Hyperoxygenation in Congenital Heart Disease (MATCH)

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ClinicalTrials.gov Identifier: NCT03136835
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Mike Seed, The Hospital for Sick Children

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

Condition or disease Intervention/treatment Phase
Hypoplastic Left Heart Syndrome Drug: Maternal Hyperoxygenation Phase 1 Phase 2

Detailed Description:
The aim of the study is to investigate the safety and feasibility of chronic maternal hyperoxygenation in pregnancies affected by fetal congenital heart disease, specifically those pregnancies in which the fetus has single ventricle physiology with aortic arch obstruction. The treatment has a potentially neuroprotective effect on the fetus. This would be desirable as the neurodevelopmental outcomes of the survivors of this form of congenital heart disease are significantly below normal. However, transplacental oxygen has not been tried in this setting, and so before embarking on a trial, the investigators need to establish that the treatment is safe and feasible. This will be accomplished by recruiting subjects which meet the eligibility criteria and commence treatment at the time of diagnosis, usually in the second trimester. The oxygen will be delivered to the mother via nasal prongs continuously at a rate of 4 L/min. Oxygen concentrators will be supplied to the subjects' homes, and a range of portable devices will also be provided to allow them to continue with usual activities of daily living. A series of follow up appointments will be arranged to check the status of the mother and fetus. Mothers will be invited to keep a diary of their adherence to the treatment. A range of routine clinical and research data on the condition of the fetus and newborn will be collected.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maternal Hyperoxygenation in Congenital Heart Disease
Actual Study Start Date : February 2, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Experimental: Pilot
Maternal Hyperoxygenation (4L/min via nasal prongs)
Drug: Maternal Hyperoxygenation
Oxygen via nasal prongs at 4L/min continuously during 2nd and 3rd trimester of pregnancy until birth
Other Name: Oxygen




Primary Outcome Measures :
  1. 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. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.)
  • Obesity
  • Infections/ anemia
  • Smoker
  • Serious cardiorespiratory co-morbidities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136835


Contacts
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Contact: Mike Seed, MD 416-813-7654 ext 202459 mike.seed@sickkids.ca
Contact: Natasha Milligan, BSc 416-586-4800 ext 6419 natasha.milligan@sickkids.ca

Locations
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Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Mike Seed, MD    416-813-7654 ext 202459    mike.seed@sickkids.ca   
Contact: Natasha Milligan, BSc    416-586-4800 ext 6419    natasa.milligan@sickkids.ca   
Principal Investigator: Mike Seed, MD         
Sub-Investigator: Fraser Golding, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Mike Seed, MD The Hospital for Sick Children

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Responsible Party: Mike Seed, Dr. Michael Seed, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03136835     History of Changes
Other Study ID Numbers: 1000048468
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Hypoplastic Left Heart Syndrome
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities