Clinical trial NCT05334966: Maternal Hyperoxygenation in Fetal Left Heart Hypoplasia
Official title: Evaluation of the Use of Supplemental Oxygen to Mothers With Fetal Left Heart Hypoplasia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Left Heart Hypoplasia
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Aortic annular dimension
timeFrame: 2 years
Secondary outcomes:
measure: Mitral annular dimension
timeFrame: years
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital Pavilion for Women
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Shaine A Morris, MD
role: PRINCIPAL_INVESTIGATOR
References: