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; twosided 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.)

Deprest, J., Benachi, A., Gratacos, E., Nicolaides, K., Berg, C., Persico, N., et al. (2021). Randomized trial of fetal surgery for moderate left diaphragmatic hernia. NEW ENGLAND JOURNAL OF MEDICINE, 385(2), 119-129 [10.1056/NEJMoa2026983].

Randomized trial of fetal surgery for moderate left diaphragmatic hernia

Vergani, P
Membro del Collaboration Group
2021

Abstract

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; twosided 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.)
Si
Articolo in rivista - Articolo scientifico
Scientifica
Adult; Female; Fetal Membranes, Premature Rupture; Fetal Therapies; Fetoscopy; Gestational Age; Hernias, Diaphragmatic, Congenital; Humans; Intention to Treat Analysis; Obstetric Labor, Premature; Patient Acuity; Pregnancy; Premature Birth; Trachea; Watchful Waiting; Balloon Occlusion;
English
Vergani, Patrizia for the TOTAL Trial for Moderate Hypoplasia Investigators
Deprest, J., Benachi, A., Gratacos, E., Nicolaides, K., Berg, C., Persico, N., et al. (2021). Randomized trial of fetal surgery for moderate left diaphragmatic hernia. NEW ENGLAND JOURNAL OF MEDICINE, 385(2), 119-129 [10.1056/NEJMoa2026983].
Deprest, J; Benachi, A; Gratacos, E; Nicolaides, K; Berg, C; Persico, N; Belfort, M; Gardener, G; Ville, Y; Johnson, A; Morini, F; Wielgos, M; Van Calster, B; Dekoninck, P; Vergani, P
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/10281/364698
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