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ACTIVE NOT RECRUITING
NCT02965638
NA

Trial of Maternal Oxygen for Fetal Left Heart Hypoplasia

Sponsor: Shaine Morris

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if maternal hyperoxygenation is an effective treatment for fetal left heart hypoplasia versus room air (placebo). This will be determined by measuring how well a baby's heart valves and their surrounding tissue are growing and functioning. In addition the investigators will examine brain growth using fetal ultrasound and MRI, and MRI of the child's brain after they are born to determine if there is greater neonatal brain maturity or mothers receiving oxygen compared to fetuses of mothers not receiving oxygen. Of note, the trial was initially randomized. However, due to low sample size and hesitation about randomization, the trial was converted to an open label study, allowing families opting for oxygen therapy to be in the intervention arm.

Official title: A Pilot Randomized Controlled Trial of Maternal Oxygen Therapy for Fetal Left Heart Hypoplasia

Key Details

Gender

FEMALE

Age Range

14 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2015-09

Completion Date

2027-07

Last Updated

2023-08-14

Healthy Volunteers

No

Interventions

OTHER

Oxygen

The intervention arm (Oxygen Group) will receive oxygen via nasal cannula at a rate of 4L of FiO2 93-100% from an oxygen concentrator up to 24 hours daily

Locations (1)

Texas Children's Hospital

Houston, Texas, United States