Evaluation of the Use of Supplemental Oxygen to Mothers With Fetal Left Heart Hypoplasia

Status: Suspended
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: Accepts Healthy Volunteers
View:

• 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

Locations
United States
Texas
Texas Children's Hospital Pavilion for Women
Houston
Time Frame
Start Date: January 2014
Completion Date: December 2025
Participants
Target number of participants: 25
Treatments
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.
Experimental: Chonic Maternal Hyperoxygenation w/ LHH
Mothers who have a fetus diagnosed with LHH and elect daily maternal hyperoxygenation therapy.
Experimental: Acute Maternal Hyperoxygenation with LHH
Mothers who have a fetus diagnosed with LHH and elect acute maternal hyperoxygenation challenge testing.
Authors
Shaine A Morris
Related Therapeutic Areas
Sponsors
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov

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