Left Heart HypoplasiaMHONCT05334966
Maternal Hyperoxygenation in Fetal Left Heart Hypoplasia
A study testing Maternal Hyperoxygenation in people with Left Heart Hypoplasia, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Heart disease is the leading cause of infant death related to birth defects. Congenital heart disease in which the left sided structures of the heart (left heart hypoplasia or LHH) are too small are among the most severe, and have some of the highest death and other complication rates. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Left Heart Hypoplasia
- What is being tested?
- Maternal Hyperoxygenation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2025
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group A, C: Fetuses with hypoplastic left sided structures or at risk of coarctation of the aorta and ALL of the following
- Any mitral annulus, aortic annulus, left ventricular end-diastolic dimension, or aortic diameter z-score less than or equal to 3.0
- Right-left ventricular size discrepancy with no other explanation of discrepancy
- Retrograde blood flow in the aortic arch from the ductus arteriosus
- Left to right flow across the foramen ovale
- Group B: Healthy Fetal controls
Show all 20Show fewer
- Mothers undergoing screening fetal echo for family history of CHD with a normal echo.
- Mothers undergoing fetal echocardiography for suspected heart disease with a normal echo
- Mothers evaluated in the fetal center with normal ultrasound
- Group D:
- Fetuses with hypoplastic left sided structures or at risk of coarctation of the aorta and any of the following
- Any mitral annulus, aortic annulus, left ventricular end-diastolic dimension, or aortic diameter z-score less than or equal to 2.0
- Right-left ventricular size discrepancy with no other explanation of discrepancy
- Continuous Doppler flow in the aortic arch concerning for coarctation
- Significantly less aortic flow than pulmonary artery flow
- Severe atrial septal aneurysm with possible obstruction of mitral valve flow
- Left superior vena cava to coronary sinus with dilated coronary sinus.
- Retrograde blood flow in the aortic arch from the ductus arteriosus
- Hypoplastic left heart syndrome (HLHS) and variants of HLHS
- Total anomalous pulmonary venous return
Who cannot join
- Multiple gestations
- Persistent arrhythmia
- Very poor ultrasound images, defined by the inability to reliably measure/evaluate all included cardiac structures (valve annuli, branch pulmonary arteries, PFO, and arch)
- Major extra cardiac anomalies
- Aneuploidy
- Maternal conditions that may alter fetal hemodynamics, including moderate to severe HTN requiring medication in pregnancy, preeclampsia, major or unrepaired maternal congenital heart disease, obstructive sleep apnea, severe asthma (non-responsive to inhaled steroid therapy), restrictive lung disease, severe anemia, maternal chronic renal disease known placentation abnormality (complete placenta previa, accrete, or percreta), and antiphospholipid ab syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Children's Hospital Pavilion for Women
Houston, Texas, 77030
About this study
Official title: Evaluation of the Use of Supplemental Oxygen to Mothers With Fetal Left Heart Hypoplasia
Heart disease is the leading cause of infant death related to birth defects. Congenital heart disease in which the left sided structures of the heart (left heart hypoplasia or LHH) are too small are among the most severe, and have some of the highest death and other complication rates.
Read the detailed description
We intend to study a new, non-invasive fetal intervention to help outcomes in children with LHH. We plan to study the effect of giving oxygen to mothers who have fetuses with small left-sided structures. We specifically will evaluate if the fetal left heart valves will grow faster if the mother breathes extra oxygen on a daily basis (at least 8 hours per day). Mothers and fetuses meeting criteria will be offered to enroll in the study. All enrolled mothers will be asked to receive oxygen continuously for the rest of the pregnancy using a non-rebreather mask. At birth, we will compare the fetuses whose mothers received oxygen to historical controls. We specifically will study how fast the left heart valves have grown.
- Conditions
- Left Heart Hypoplasia
- Being tested
- Maternal Hyperoxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal HyperoxygenationOther
Also called Oxygen
Oxygen is given to mothers at 8L through a non-rebreather mask.
| Study group | Role | What they receive |
|---|---|---|
| Historical LHH Controls | No intervention | Previous women with a dx of fetal LHH and whose care was continued at Texas Children's Hospital. |
| Healthy Fetal Controls | Placebo comparator | Healthy mothers with healthy fetuses that will come in monthly for fetal echcos starting at 20 wks. Receives: Other: Maternal Hyperoxygenation |
| Chonic Maternal Hyperoxygenation w/ LHH | Experimental | Mothers who have a fetus diagnosed with LHH and elect daily maternal hyperoxygenation therapy. Receives: Other: Maternal Hyperoxygenation |
| Acute Maternal Hyperoxygenation with LHH | Experimental | Mothers who have a fetus diagnosed with LHH and elect acute maternal hyperoxygenation challenge testing. Receives: Other: Maternal Hyperoxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic annular dimension
By fetal echo the size of the aortic annulus in mm
Measured: 2 years
Secondary outcomes (1)
Mitral annular dimension
By fetal echo the size of the mitral valve annulus in mm
Measured: years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study startJan 2014
- Primary completionApr 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Heart HypoplasiaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaine Morris, Baylor College of Medicine
- Investigators
- Shaine A Morris, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334966
- Sponsor's protocol ID
- H-33802
- Acronym
- MHO
- Status last verified
- Aug 2023
- First submitted
- 4 May 2015
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Supplemental Oxygen to Mothers With Fetal Left Heart Hypoplasia
- ClinicalTrials.gov ID
- NCT05334966
- Acronym / sponsor ID
- MHO / H-33802
- Conditions
- Left Heart Hypoplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Apr 2022 (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.
Heart disease is the leading cause of infant death related to birth defects. Congenital heart disease in which the left sided structures of the heart (left heart hypoplasia or LHH) are too small are among the most severe, and have some of the highest death and other complication rates.
Detailed description
We intend to study a new, non-invasive fetal intervention to help outcomes in children with LHH. We plan to study the effect of giving oxygen to mothers who have fetuses with small left-sided structures. We specifically will evaluate if the fetal left heart valves will grow faster if the mother breathes extra oxygen on a daily basis (at least 8 hours per day). Mothers and fetuses meeting criteria will be offered to enroll in the study. All enrolled mothers will be asked to receive oxygen continuously for the rest of the pregnancy using a non-rebreather mask. At birth, we will compare the fetuses whose mothers received oxygen to historical controls. We specifically will study how fast the left heart valves have grown.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Historical LHH Controls | No intervention | –Previous women with a dx of fetal LHH and whose care was continued at Texas Children's Hospital. |
| Healthy Fetal Controls | Placebo comparator | Other: Maternal HyperoxygenationHealthy mothers with healthy fetuses that will come in monthly for fetal echcos starting at 20 wks. |
| Chonic Maternal Hyperoxygenation w/ LHH | Experimental | Other: Maternal HyperoxygenationMothers who have a fetus diagnosed with LHH and elect daily maternal hyperoxygenation therapy. |
| Acute Maternal Hyperoxygenation with LHH | Experimental | Other: Maternal HyperoxygenationMothers who have a fetus diagnosed with LHH and elect acute maternal hyperoxygenation challenge testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Group A, C: Fetuses with hypoplastic left sided structures or at risk of coarctation of the aorta and ALL of the following
- Group B: Healthy Fetal controls
- Group D:
- Fetuses with hypoplastic left sided structures or at risk of coarctation of the aorta and any of the following
- Any mitral annulus, aortic annulus, left ventricular end-diastolic dimension, or aortic diameter z-score less than or equal to 2.0
Key exclusion criteria (6 listed)
- Multiple gestations
- Persistent arrhythmia
- Very poor ultrasound images, defined by the inability to reliably measure/evaluate all included cardiac structures (valve annuli, branch pulmonary arteries, PFO, and arch)
- Major extra cardiac anomalies
- Aneuploidy
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 is given to mothers at 8L through a non-rebreather mask. | Other | Acute Maternal Hyperoxygenation with LHH, Chonic Maternal Hyperoxygenation w/ LHH, Healthy Fetal Controls |
Primary outcome
Aortic annular dimension
Time frame: 2 years
By fetal echo the size of the aortic annulus in mm
1 secondary outcome
Mitral annular dimension
Time frame: years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
Related trials for Left Heart Hypoplasia
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Trial of Maternal Oxygen for Fetal Left Heart Hypoplasia
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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.
Shaine A Morris, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Hyperoxygenation in people with Left Heart Hypoplasia, run by Baylor College of Medicine at 1 site in United States.
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 20 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Aortic annular dimension (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2023.