Maternal Hyperoxygenation in Fetal Left Heart Hypoplasia (MHO)

August 9, 2023 updated by: Shaine Morris, Baylor College of Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital Pavilion for Women

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • Oxygen

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Aortic annular dimension
Time Frame: 2 years
By fetal echo the size of the aortic annulus in mm
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mitral annular dimension
Time Frame: years
By fetal echo the size of the mitral valve annulus in mm
years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baylor College of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shaine A Morris, MD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-33802

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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