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Randomized trial of fetal surgery for severe left diaphragmatic hernia

New England Journal of Medicine Jun 12, 2021

Deprest JA, Nicolaides, KH, et al. - In observational studies, fetoscopic endoluminal tracheal occlusion (FETO) has been linked with enhanced survival among infants with severe pulmonary hypoplasia due to isolated congenital diaphragmatic hernia on the left side, researchers conducted randomized trials examining this correlation. Women carrying singleton fetuses with severe isolated congenital diaphragmatic hernia on the left side were randomly assigned to FETO at 27 to 29 weeks of gestation or expectant care. Standardized postnatal care followed both treatments. After the third interim analysis, early termination of the trial for efficacy was done. In an intention-to-treat analysis performed including 80 women, survival to discharge was recorded for 40% of infants (16 of 40) in the FETO group vs 15% (6 of 40) in the expectant care group. This suggests that in these infants, FETO performed at 27 to 29 weeks of gestation is linked with a significant benefit over expectant care with respect to survival to discharge; this benefit was sustained to 6 months of age. Increased risks of preterm, prelabor rupture of membranes and preterm birth were recorded in correlation with undergoing FETO.

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