Randomized Trial of Fetal Surgery for Severe Left Diaphragmatic Hernia.

ABSTRACT:

Background

Observational studies have shown that fetoscopic endoluminal tracheal occlusion (FETO) has been associated with increased survival among infants with severe pulmonary hypoplasia due to isolated congenital diaphragmatic hernia on the left side, but data from randomized trials are lacking.

Methods

In this open-label trial conducted at centers with experience in FETO and other types of prenatal surgery, we randomly assigned, in a 1:1 ratio, women carrying singleton fetuses with severe isolated congenital diaphragmatic hernia on the left side to FETO at 27 to 29 weeks of gestation or expectant care. Both treatments were followed by standardized postnatal care. The primary outcome was infant survival to discharge from the neonatal intensive care unit. We used a group-s

SUBMITTER: Deprest JA 

PROVIDER: S-EPMC7613453 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature