Evaluation of the Use of Supplemental Oxygen to Mothers With Fetal Left Heart Hypoplasia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Left Heart Hypoplasia
- Sponsor
- Baylor College of Medicine
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Aortic annular dimension
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Shaine Morris
Associate Professor
Baylor College of Medicine
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
- •Fetuses with hypoplastic left sided structures or at risk of coarctation of the aorta and any of the following
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Aortic annular dimension
Time Frame: 2 years
By fetal echo the size of the aortic annulus in mm
Secondary Outcomes
- Mitral annular dimension(years)