Hypoplastic Left Heart SyndromePhase 1/2MATCHNCT03136835
Maternal Hyperoxygenation in Congenital Heart Disease
A Phase 1/2 study testing Maternal Hyperoxygenation in people with Hypoplastic Left Heart Syndrome, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
A pilot study investigating the safety and feasibility of chronic maternal hyperoxygenation in the setting of fetal congenital heart disease Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypoplastic Left Heart Syndrome
- What is being tested?
- Maternal Hyperoxygenation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 2 Feb 2018to 22 Mar 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 20-32 weeks gestation
- Diagnosis of fetus with a single ventricular ventricular heart
- Delivering at Mount Sinai Hospital
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
A pilot study investigating the safety and feasibility of chronic maternal hyperoxygenation in the setting of fetal congenital heart disease
Read the 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, and by comparing outcomes with a historical cohort with CHD diagnoses with no oxygen intervention. The oxygen will be delivered to the mother via nasal prongs continuously at a rate of up to 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.
- Conditions
- Hypoplastic Left Heart Syndrome
- Being tested
- Maternal Hyperoxygenation
- Medical subject headings
- Hypoplastic Left Heart Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal HyperoxygenationDrug
Also called Oxygen
Oxygen via nasal prongs at up to 4L/min continuously during 2nd and 3rd trimester of pregnancy until birth
| Study group | Role | What they receive |
|---|---|---|
| Pilot | Experimental | Maternal Hyperoxygenation (4L/min via nasal prongs) Receives: Drug: Maternal Hyperoxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The general condition of the child and mother at the time of birth
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.
Measured: 2 years
The duration of oxygen therapy tolerated by the subjects
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start2 Feb 2018
- Primary completion22 Mar 2024
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypoplastic Left Heart SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mike Seed, The Hospital for Sick Children
- Investigators
- Mike Seed, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136835
- Sponsor's protocol ID
- 1000048468
- Acronym
- MATCH
- Status last verified
- Mar 2024
- First submitted
- 28 Oct 2015
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee FT, Sun L, Szabo A, Milligan N, Saini A, Chetan D, Hunt JL, Macgowan CK, Freud L, Jaeggi E, Van Mieghem T, Kingdom J, Miller SP, Seed M. Safety and feasibility pilot study of continuous low-dose maternal supplemental oxygen in fetal single ventricle heart disease. Ultrasound Obstet Gynecol. 2024 Oct;64(4):493-503. doi: 10.1002/uog.27657.
PubMed 38629477
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Hyperoxygenation in Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT03136835
- Acronym / sponsor ID
- MATCH / 1000048468
- Conditions
- Hypoplastic Left Heart Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot study investigating the safety and feasibility of chronic maternal hyperoxygenation in the setting of fetal congenital heart disease
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, and by comparing outcomes with a historical cohort with CHD diagnoses with no oxygen intervention. The oxygen will be delivered to the mother via nasal prongs continuously at a rate of up to 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot | Experimental | Drug: Maternal HyperoxygenationMaternal Hyperoxygenation (4L/min via nasal prongs) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 20-32 weeks gestation
- Diagnosis of fetus with a single ventricular ventricular heart
- Delivering at Mount Sinai Hospital
- Written informed consent
Key exclusion criteria (6 listed)
- Opting for termination of pregnancy/ comfort care
- Normal exclusions for MRI (e.g. claustrophobia, cardiac pacemaker, etc.)
- BMI >37.0
- Infections/ anemia
- Smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal HyperoxygenationAlso: OxygenOxygen via nasal prongs at up to 4L/min continuously during 2nd and 3rd trimester of pregnancy until birth | Drug | Pilot |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Derived from this study: PubMed 38629477Lee FT, Sun L, Szabo A, Milligan N, Saini A, Chetan D, Hunt JL, Macgowan CK, Freud L, Jaeggi E, Van Mieghem T, Kingdom J, Miller SP, Seed M. Safety and feasibility pilot study of continuous low-dose maternal supplemental oxygen in fetal single ventricle heart disease. Ultrasound Obstet Gynecol. 2024 Oct;64(4):493-503. doi: 10.1002/uog.27657.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Seed, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Maternal Hyperoxygenation in people with Hypoplastic Left Heart Syndrome, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The general condition of the child and mother at the time of birth (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03136835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.