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Maternal Hyperoxygenation in Fetal Left Heart Hypoplasia (MHO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05334966
Recruitment Status : Suspended (Replaced by clinical trial)
First Posted : April 19, 2022
Last Update Posted : April 19, 2022
Sponsor:
Information provided by (Responsible Party):
Judith Anne Becker, Baylor College of Medicine

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Left Heart Hypoplasia Other: Maternal Hyperoxygenation Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Use of Supplemental Oxygen to Mothers With Fetal Left Heart Hypoplasia
Study Start Date : January 2014
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Historical LHH Controls
Previous women with a dx of fetal LHH and whose care was continued at Texas Children's Hospital.
Placebo Comparator: Healthy Fetal Controls
Healthy mothers with healthy fetuses that will come in monthly for fetal echcos starting at 20 wks.
 Other: Maternal Hyperoxygenation
Oxygen is given to mothers at 8L through a non-rebreather mask.
Other Name: Oxygen
Experimental: Chonic Maternal Hyperoxygenation w/ LHH
Mothers who have a fetus diagnosed with LHH and elect daily maternal hyperoxygenation therapy.
 Other: Maternal Hyperoxygenation
Oxygen is given to mothers at 8L through a non-rebreather mask.
Other Name: Oxygen
Experimental: Acute Maternal Hyperoxygenation with LHH
Mothers who have a fetus diagnosed with LHH and elect acute maternal hyperoxygenation challenge testing.
 Other: Maternal Hyperoxygenation
Oxygen is given to mothers at 8L through a non-rebreather mask.
Other Name: Oxygen


Outcome Measures
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Primary Outcome Measures :
  1. Aortic annular dimension [ Time Frame: 2 years ]
    By fetal echo the size of the aortic annulus in mm


Secondary Outcome Measures :
  1. Mitral annular dimension [ Time Frame: years ]
    By fetal echo the size of the mitral valve annulus in mm


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

    • 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

Exclusion criteria:

  • 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
Contacts and Locations
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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): NCT05334966


Locations
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United States, Texas
Texas Children's Hospital Pavilion for Women
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Shaine A Morris, MD Baylor College of Medicine
More Information
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Responsible Party: Judith Anne Becker, Assistant Professor, Non-Invasive Diagnostic Imaging, Pediatric Echocardiography, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT05334966    
Other Study ID Numbers: H-33802
First Posted: April 19, 2022    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022