title: A randomized controlled trial of fetal endoscopic tracheal occlusion versus postnatal management of severe isolated congenital diaphragmatic hernia.
abstract: OBJECTIVE
  Severe pulmonary hypoplasia and pulmonary arterial hypertension are associated with reduced survival in congenital diaphragmatic hernia (CDH). We aimed to determine whether fetal endoscopic tracheal occlusion (FETO) improves survival in cases of severe isolated CDH.
  
  
  METHODS
  Between May 2008 and July 2010, patients whose fetuses had severe isolated CDH (lung-to-head ratio < 1.0, liver herniation into the thoracic cavity and no other detectable anomalies) were assigned randomly to FETO or to no fetal intervention (controls). FETO was performed under maternal epidural anesthesia supplemented with fetal intramuscular anesthesia. Tracheal balloon placement was achieved with ultrasound guidance and fetoscopy between 26 and 30 weeks of gestation. All cases that underwent FETO were delivered by the EXIT procedure. Postnatal therapy was the same for both treated fetuses and controls. The primary outcome was survival to 6 months of age. Other maternal and neonatal outcomes were also evaluated.
  
  
  RESULTS
  Twenty patients were enrolled randomly to FETO and 21 patients to standard postnatal management. The mean gestational age at randomization was similar in both groups (P = 0.83). Delivery occurred at 35.6 ± 2.4 weeks in the FETO group and at 37.4 ± 1.9 weeks in the controls (P < 0.01). In the intention-to-treat analysis, 10/20 (50.0%) infants in the FETO group survived, while 1/21 (4.8%) controls survived (relative risk (RR), 10.5 (95% CI, 1.5-74.7), P < 0.01). In the received-treatment analysis, 10/19 (52.6%) infants in the FETO group and 1/19 (5.3%) controls survived (RR, 10.0 (95% CI, 1.4-70.6) P < 0.01).
  
  
  CONCLUSIONS
  FETO improves neonatal survival in cases with isolated severe CDH.
authors.affiliation: Department of Obstetrics and Gynecology, Universidade de São Paulo, São Paulo, Brazil. rodrigoruano@usp.br
authors.forename: R
authors.initials: R
authors.lastname: Ruano
authors.forename: C T
authors.initials: CT
authors.lastname: Yoshisaki
authors.forename: M M
authors.initials: MM
authors.lastname: da Silva
authors.forename: M E J
authors.initials: ME
authors.lastname: Ceccon
authors.forename: M S
authors.initials: MS
authors.lastname: Grasi
authors.forename: U
authors.initials: U
authors.lastname: Tannuri
authors.forename: M
authors.initials: M
authors.lastname: Zugaib
mesh_terms: D000293:Adolescent; D000328:Adult; D021721:Balloon Occlusion / Q000379:methods*; D001938:Brazil / Q000453:epidemiology; D005260:Female; D005332:Fetoscopy / Q000379:methods*; D005865:Gestational Age; D006548:Hernia, Diaphragmatic / Q000196:embryology / Q000401:mortality / Q000503:physiopathology / Q000628:therapy; D065630:Hernias, Diaphragmatic, Congenital; D006801:Humans; D007223:Infant; D008297:Male; D016017:Odds Ratio; D011247:Pregnancy; D014132:Trachea / Q000196:embryology / Q000473:pathology* / Q000503:physiopathology; D016896:Treatment Outcome; D055815:Young Adult