An interventional study of Maternal Hyperoxygenation in Left Heart Hypoplasia, sponsored by Baylor College of Medicine. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
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.
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.
Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Group A, C: Fetuses with hypoplastic left sided structures or at risk of coarctation of the aorta and ALL of the following
Group B: Healthy Fetal controls
Fetuses with hypoplastic left sided structures or at risk of coarctation of the aorta and any of the following
Exclusion criteria:
Previous women with a dx of fetal LHH and whose care was continued at Texas Children's Hospital.
Healthy mothers with healthy fetuses that will come in monthly for fetal echcos starting at 20 wks.
Other: Maternal Hyperoxygenation
Mothers who have a fetus diagnosed with LHH and elect daily maternal hyperoxygenation therapy.
Other: Maternal Hyperoxygenation
Mothers who have a fetus diagnosed with LHH and elect acute maternal hyperoxygenation challenge testing.
Other: Maternal Hyperoxygenation
Oxygen is given to mothers at 8L through a non-rebreather mask.
Also known as: Oxygen
Aortic annular dimension
By fetal echo the size of the aortic annulus in mm
Time frame: 2 years
Mitral annular dimension
By fetal echo the size of the mitral valve annulus in mm
Time frame: years
This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Baylor College of Medicine