Randomized Trial of Fetal Surgery for Severe Left Diaphragmatic Hernia

In fetuses with severe left congenital diaphragmatic hernia (CDH), fetoscopic endoluminal tracheal occlusion (FETO) has been associated with improved survival, but randomized trial data were lacking. In this open-label trial across 13 countries, women carrying singleton fetuses with isolated severe left CDH were randomized to undergo FETO at 27–29 weeks of gestation or expectant management. The trial was stopped early due to clear benefit: survival to neonatal discharge was significantly higher in the FETO group (40%) than in the expectant group (15%). FETO increased the risk of preterm rupture of membranes and preterm delivery but did not cause serious maternal complications. Results support the use of FETO for severe left CDH in experienced centers.

In fetuses with severe left congenital diaphragmatic hernia (CDH), fetoscopic endoluminal tracheal occlusion (FETO) has been associated with improved survival, but randomized trial data were lacking. In this open-label trial across 13 countries, women carrying singleton fetuses with isolated severe left CDH were randomized to undergo FETO at 27–29 weeks of gestation or expectant management. The trial was stopped early due to clear benefit: survival to neonatal discharge was significantly higher in the FETO group (40%) than in the expectant group (15%). FETO increased the risk of preterm rupture of membranes and preterm delivery but did not cause serious maternal complications. Results support the use of FETO for severe left CDH in experienced centers.