NCT05334966

Maternal Hyperoxygenation in Fetal Left Heart Hypoplasia

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Left Heart Hypoplasia

Interventions

Type	Name	Description
OTHER	Maternal Hyperoxygenation	Oxygen is given to mothers at 8L through a non-rebreather mask.

Timeline

• Start date: 2014-01-01
• Primary completion: 2024-04-01
• Completion: 2025-12-01
• First posted: 2022-04-19
• Last updated: 2023-08-14

Locations

1 site across 1 country: United States