Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia
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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; Wielgoś, Mirosław; Van Calster, Ben; DeKoninck, Philip L J; TOTAL Trial for Moderate Hypoplasia Investigators.
In: NEW ENGL J MED, Vol. 385, No. 2, 08.07.2021, p. 119-129.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia
AU - Deprest, Jan A
AU - Benachi, Alexandra
AU - Gratacos, Eduard
AU - Nicolaides, Kypros H
AU - Berg, Christoph
AU - Persico, Nicola
AU - Belfort, Michael
AU - Gardener, Glenn J
AU - Ville, Yves
AU - Johnson, Anthony
AU - Morini, Francesco
AU - Wielgoś, Mirosław
AU - Van Calster, Ben
AU - DeKoninck, Philip L J
AU - TOTAL Trial for Moderate Hypoplasia Investigators
AU - Hecher, Kurt
N1 - Copyright © 2021 Massachusetts Medical Society.
PY - 2021/7/8
Y1 - 2021/7/8
N2 - 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.).
AB - 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.).
KW - Adult
KW - Balloon Occlusion/adverse effects
KW - Female
KW - Fetal Membranes, Premature Rupture/epidemiology
KW - Fetal Therapies/adverse effects
KW - Fetoscopy
KW - Gestational Age
KW - Hernias, Diaphragmatic, Congenital/mortality
KW - Humans
KW - Intention to Treat Analysis
KW - Obstetric Labor, Premature/epidemiology
KW - Patient Acuity
KW - Pregnancy
KW - Premature Birth/epidemiology
KW - Trachea/surgery
KW - Watchful Waiting
U2 - 10.1056/NEJMoa2026983
DO - 10.1056/NEJMoa2026983
M3 - SCORING: Journal article
C2 - 34106555
VL - 385
SP - 119
EP - 129
JO - NEW ENGL J MED
JF - NEW ENGL J MED
SN - 0028-4793
IS - 2
ER -