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

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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 14
Maximum Age: 60
Healthy Volunteers: No
View:

• Mothers carrying fetuses with small left sided structures likely needing neonatal intervention, defined as the following on fetal echocardiography:

• Sum of aortic and mitral valve z-scores (standard deviation based on gestational age) less than -4.5

• Flow across the atrial septum either bidirectional or left to right

• Transverse aortic arch or isthmus z-score less than 2.0.

Locations
United States
Texas
Texas Children's Hospital
Recruiting
Houston
Contact Information
Primary
Teniola Shittu, MPH
txshittu@texaschildrens.org
832-826-5613
Backup
Donna Capps
Donna.Capps@bcm.edu
832-826-5953
Time Frame
Start Date: September 2015
Estimated Completion Date: July 2024
Participants
Target number of participants: 12
Treatments
Active Comparator: Oxygen Group
The mothers will be asked to be on 4 liter of oxygen through nasal cannula up to 24 hours a day. The subjects will be blinded to their treatment.
No Intervention: Control Group
These mothers will not undergo CMH therapy
Authors
Shaine A Morris
Sponsors
Leads: Shaine Morris

This content was sourced from clinicaltrials.gov

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