Investigators from multiple international institutions conducted an open-label randomized controlled trial to assess the efficacy of fetal endoluminal tracheal obstruction (FETO) in fetuses with severe pulmonary hypoplasia secondary to left-sided diaphragmatic hernia. With FETO, a balloon is inserted into the trachea of an affected fetus prior to 30 weeks’ gestation and inflated; the balloon is deflated at a later point. The study was conducted at 10 FETO centers and 26 NICUs in multiple countries. Women >18 years old with a fetus with a left diaphragmatic hernia and severe pulmonary hypoplasia (fetal lung-to-head ratio <25% of predicted based on gestational age) who were <33 weeks, 6 days gestation were enrolled and randomized to FETO at 27 weeks, 0 days to 33 weeks, 6 days gestation, or expectant care. For those randomized to FETO, ultrasound guided puncture and removal of the balloon was scheduled for 34 weeks, 0 days to 34 weeks, 6 days gestation. The primary study outcome was survival until NICU discharge. Secondary outcomes included survival to 6 months of age, obstetrical complications, and adverse events. The relative risk (RR) for these outcomes were compared between the participants in the 2 treatment groups. There were planned interim analyses with specific criteria for early conclusion of the trial.
Among 95 enrolled women with fetuses with diaphragmatic hernias, 47 were randomized to FETO and 48 to expectant care. The trial was stopped following the interim analysis conducted on 80 participants (40 in each group). Baseline characteristics of those in the 2 groups were similar. Among those randomized to FETO, median duration of balloon inflation was 3 4 days, and median change in lung-to-head ratio from baseline was 67%. Among 40 infants in the FETO group, 16 survived until NICU discharge (40%) compared to 6 of 40 (15%) in the expectant care group (RR, 2.60; 95% CI, 1.19, 5.93). Survival to 6 months of age also was significantly better in those treated with FETO than in infants receiving expectant care (RR, 2.67; 95% CI, 1.22, 6.11). The median gestational age at birth was 34 weeks, 4 days for infants in the FETO group and 38 weeks, 3 days for those receiving expectant care. Preterm birth occurred in 75% and 33%, respectively, of women randomized to FETO or expectant birth (RR, 2.59; 95% CI, 1.59, 4.52). One infant in the FETO group died because of procedure-related placental laceration during balloon removal, and 1 infant died when the balloon was in place at birth and could not be deflated properly.
The authors conclude that FETO improves survival in infants with left-sided congenital diaphragmatic hernia and severe pulmonary hypoplasia.
Dr Lesser has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a...