The USFetus.org, conducts research in Fetal Therapy. With the support of The Brianna Marie Foundation, they are running a clinical trial assessing the fetoscopic treatment of open spina bifida. Spina bifida affects approximately 1:1000 pregnancies and is associated with long-term neurological adverse effects. Studies using open fetal surgery have shown that antenatal correction of the condition improves the outcome of babies.
The USFetus group developed a percutaneous fetoscopic technique that aims to achieve similar or better infant outcomes while decreasing the attendant risks to the mother. They have made adjustments to our original surgical technique that was funded in part by the Brianna Marie Foundation. Based on this change, they need to expand the number of subjects beyond those originally planned to reach more valid conclusions. The additional funds from the Brianna Marie Foundation will be used to cover regulatory expenses associated with the continuation of the study. The study is being monitored by the FDA and is approved by the Western IRB and the IRB of the University of Southern California. Upon completion of the study, the results will be submitted for publication in a medical journal.