Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia

Deprest, Jan A. ; Benachi, Alexandra ; Gratacos, Eduard ; Nicolaides, Kypros H. ; Berg, Christoph ; Persico, Nicola ; Belfort, Michael ; Gardener, Glenn J. ; Ville, Yves ; Johnson, Anthony ; Morini, Francesco ; Wielgos, Miroslaw ; Van Calster, Ben ; DeKoninck, Philip L.J. ; for the TOTAL Trial for Moderate Hypoplasia Investigators ; Tajada Duaso, Mauricio (Universidad de Zaragoza)

Resumen: Background
Fetoscopic endoluminal tracheal occlusion (FETO) has been associated with increased postnatal survival among infants with severe pulmonary hypoplasia due to isolated congenital diaphragmatic hernia on the left side, but data are lacking to inform its effects in infants with moderate disease.

Methods
In this open-label trial conducted at many centers with experience in FETO and other types of prenatal surgery, we randomly assigned, in a 1:1 ratio, women carrying singleton fetuses with a moderate isolated congenital diaphragmatic hernia on the left side to FETO at 30 to 32 weeks of gestation or expectant care. Both treatments were followed by standardized postnatal care. The primary outcomes were infant survival to discharge from a neonatal intensive care unit (NICU) and survival without oxygen supplementation at 6 months of age.

Results
In an intention-to-treat analysis involving 196 women, 62 of 98 infants in the FETO group (63%) and 49 of 98 infants in the expectant care group (50%) survived to discharge (relative risk , 1.27; 95% confidence interval [CI], 0.99 to 1.63; two-sided P=0.06). At 6 months of age, 53 of 98 infants (54%) in the FETO group and 43 of 98 infants (44%) in the expectant care group were alive without oxygen supplementation (relative risk, 1.23; 95% CI, 0.93 to 1.65). The incidence of preterm, prelabor rupture of membranes was higher among women in the FETO group than among those in the expectant care group (44% vs. 12%; relative risk, 3.79; 95% CI, 2.13 to 6.91), as was the incidence of preterm birth (64% vs. 22%, respectively; relative risk, 2.86; 95% CI, 1.94 to 4.34), but FETO was not associated with any other serious maternal complications. There were two spontaneous fetal deaths (one in each group) without obvious cause and one neonatal death that was associated with balloon removal.

Conclusions
This trial involving fetuses with moderate congenital diaphragmatic hernia on the left side did not show a significant benefit of FETO performed at 30 to 32 weeks of gestation over expectant care with respect to survival to discharge or the need for oxygen supplementation at 6 months. FETO increased the risks of preterm, prelabor rupture of membranes and preterm birth. (Funded by the European Commission and others; TOTAL ClinicalTrials.gov number, NCT00763737. opens in new tab.)

Idioma: Inglés

DOI: 10.1056/NEJMoa2026983

Año: 2021

Publicado en: NEW ENGLAND JOURNAL OF MEDICINE 385, 2 (2021), 119-129
ISSN: 0028-4793

Factor impacto JCR: 176.082 (2021)

Categ. JCR: MEDICINE, GENERAL & INTERNAL rank: 2 / 172 = 0.012 (2021) - Q1 - T1

Factor impacto CITESCORE: 110.5 - Medicine (Q1)

Factor impacto SCIMAGO: 24.907 - Medicine (miscellaneous) (Q1)

Financiación: info:eu-repo/grantAgreement/EC/FP6/37409/EU/Soft tissue engineering for congenital birth defects in children: new treatment modalities for spina bifida, urogenital and abdominal wall defects/EUROSTEC

Tipo y forma: Artículo (Versión definitiva)

Área (Departamento): Área Obstetricia y Ginecología (Dpto. Cirugía)