Fetal Intervention For Severe Congenital Diaphragmatic Hernia

In this study we offer minimally invasive, fetal tracheal occlusion to patients with the most severe form of congenital diaphragmatic hernia (CDH). This study was made possible by an investigational device exemption from the Food and Drug Administration.

A detailed description of the study is available at ClinicalTrials.gov NCT00966823.

Background

Fetal intervention to prevent pulmonary hypoplasia—the main danger associated with congenital diaphragmatic hernia (CDH)—began in the 1990s with open fetal surgery. As in utero techniques evolved, open fetal surgery was replaced by fetal tracheal occlusion, which has been shown to result in accelerated growth of hypoplastic lungs. In the last decade, research has focused on further understanding the mechanisms involved in accelerated lung growth following fetal tracheal occlusion. Occlusion can now be performed through a single entry port—a technique developed through our program. This technique uses an inflatable and detachable balloon to occlude the fetal trachea.

Rationale

The multicentric Eurofoetus study showed that fetal endoscopic tracheal occlusion produced positive results in severe cases of CDH: fetuses that were identified as having a survival rate of less than 10 to 40 percent, despite all current methods of postnatal therapy. In this group, endoscopic tracheal occlusion increased the survival rate to 50 to 80 percent. We believe that for babies with severe CDH, this treatment technique will allow enough accelerated lung growth for an intermediate or good prognosis, and a predicted survival rate of greater than 50 to 65 percent.

Diaphragmatic hernia with intestinal loops (arrows) in the chest.