Researchers at the University of Sao Paulo (USP; Brazil) conducted a randomized trial between May 2008 and July 2010 to compare the safety and efficacy of FETO for the treatment of severe isolated CDH. In all, 20 patients were assigned randomly to undergo FETO and 21 patients were assigned to no prenatal intervention (control group). FETO was performed under maternal epidural anesthesia supplemented with fetal intramuscular anesthesia; tracheal balloon placement with ultrasound guidance and fetoscopy was completed between 26 and 30 weeks of gestation. The primary outcome was survival to 6 months of age, and other maternal and neonatal outcomes were also evaluated.
The results showed that delivery occurred at a mean 35.6 weeks in the FETO group and at 37.4 weeks in the control group. In all, 50% of the infants in the FETO group and one infant out of 21 (4.8%) in the control group survived, a ten-fold increase in infant survival rate. According to the researchers, the FETO procedure appears to improve survival by enhancing pulmonary growth as a consequence of fetal tracheal occlusion. The study was published in the December 14, 2011, issue of Ultrasound in Obstetrics & Gynecology.
“The present study allows the establishment of this treatment as standard care for severe forms of congenital diaphragmatic hernia,” concluded lead author Rodrigo Ruano, MD, PhD, and colleagues of the department of obstetrics and gynecology.
CDH is a congenital malformation of the diaphragm that allows the abdominal organs to enter the chest cavity and interfere with proper lung formation. The most common type of CDH is a Bochdalek hernia; other types include Morgagni's hernia, diaphragm eventration, and central tendon defects of the diaphragm. CDH is a life-threatening pathology in infants, and a major cause of death due to two complications: pulmonary hypoplasia and pulmonary hypertension. Newborns with CDH often have severe respiratory distress, which can be life threatening unless treated appropriately.
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