Maternal Hyperoxygenation in Fetal Left Heart Hypoplasia

NCT ID: NCT05334966

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2025-12-31

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Historical LHH Controls

Previous women with a dx of fetal LHH and whose care was continued at Texas Children's Hospital.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy Fetal Controls

Healthy mothers with healthy fetuses that will come in monthly for fetal echcos starting at 20 wks.

Group Type: PLACEBO_COMPARATOR

Maternal Hyperoxygenation

Intervention Type: OTHER

Oxygen is given to mothers at 8L through a non-rebreather mask.

Chonic Maternal Hyperoxygenation w/ LHH

Mothers who have a fetus diagnosed with LHH and elect daily maternal hyperoxygenation therapy.

Group Type: EXPERIMENTAL

Maternal Hyperoxygenation

Intervention Type: OTHER

Oxygen is given to mothers at 8L through a non-rebreather mask.

Acute Maternal Hyperoxygenation with LHH

Mothers who have a fetus diagnosed with LHH and elect acute maternal hyperoxygenation challenge testing.

Group Type: EXPERIMENTAL

Maternal Hyperoxygenation

Intervention Type: OTHER

Oxygen is given to mothers at 8L through a non-rebreather mask.

Interventions

Maternal Hyperoxygenation

Oxygen is given to mothers at 8L through a non-rebreather mask.

Intervention Type: OTHER

Other Intervention Names

Oxygen

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Shaine Morris

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaine A Morris, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Texas Children's Hospital Pavilion for Women

Houston, Texas, United States

Countries

United States

Other Identifiers

H-33802

Identifier Type: -

Identifier Source: org_study_id