Status:
UNKNOWN
Maternal Hyperoxygenation in Fetal Left Heart Hypoplasia
Lead Sponsor:
Baylor College of Medicine
Conditions:
Left Heart Hypoplasia
Eligibility:
FEMALE
18+ years
Phase:
NA
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 a...
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 structur...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05334966
Start Date
January 1 2014
End Date
December 1 2025
Last Update
August 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Texas Children's Hospital Pavilion for Women
Houston, Texas, United States, 77030