Fetoscopic endoluminal tracheal occlusion (FETO) offers significant benefit for singleton fetuses with severe, but not moderate, isolated congenital diaphragmatic hernia on the left side, according to two studies published online June 8 in the New England Journal of Medicine to coincide with the International Society for Prenatal Diagnosis 25th International Conference on Prenatal Diagnosis and Therapy, held virtually from June 6 to 8.
Jan A. Deprest, M.D., Ph.D., from the KU Leuven in Belgium, and colleagues conducted an open-label trial involving 80 women carrying singleton fetuses with severe isolated congenital diaphragmatic hernia on the left side who were randomly assigned to either FETO at 27 to 29 weeks of gestation or expectant care (40 women to each), both followed by standardized postnatal care. After the third interim analysis, the trial was stopped early for efficacy. The researchers found that 40 and 15 percent of infants born to women in the FETO and expectant care groups, respectively, survived to discharge (relative risk, 2.67). Survival to six months of age was identical (relative risk, 2.67).
In a second study, Deprest and colleagues randomly assigned 196 women carrying singleton fetuses with a moderate isolated congenital diaphragmatic hernia on the left side to either FETO at 30 to 32 weeks of gestation or expectant care, followed by standardized postnatal care. The researchers found that in the intention-to-treat analysis, 63 percent of infants in the FETO group and 50 percent in the expectant care group survived to discharge (relative risk, 1.27; 95 percent confidence interval, 0.99 to 1.63; two-sided P = 0.06). At six months of age, 54 and 44 percent of infants, respectively, were alive without oxygen supplementation (relative risk, 1.23; 95 percent confidence interval, 0.93 to 1.65).
“The current reports serve as a critical basis for future studies to improve outcomes in pregnancies complicated by fetal congenital diaphragmatic hernia and in infants,” write the authors of an accompanying editorial.