A randomized controlled trial of fetal endoscopic tracheal occlusion versus postnatal management of severe isolated congenital diaphragmatic hernia

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dc.contributor Sistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.author RUANO, R. FMUSP-HC
dc.date.issued 2012
dc.identifier.citation ULTRASOUND IN OBSTETRICS & GYNECOLOGY, v.39, n.1, p.20-27, 2012
dc.identifier.issn 0960-7692
dc.identifier.uri http://observatorio.fm.usp.br/handle/OPI/835
dc.description.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 receivedtreatment 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). Conclusion FETO improves neonatal survival in cases with isolated severe CDH.
dc.description.sponsorship · CNPq (Conselho Nacional de Desenvolvimento de Pesquisa e Tecnologia do Brasil) [SISNEP CAAE - 0926.0.015.000-07]
dc.language.iso eng
dc.publisher WILEY-BLACKWELL
dc.relation.ispartof Ultrasound in Obstetrics & Gynecology
dc.rights restrictedAccess
dc.subject congenital diaphragmatic hernia; fetal abnormalities; fetal surgery; FETO; fetoscopy; prenatal diagnosis; pulmonary hypertension; pulmonary hypoplasia
dc.subject.other head circumference ratio; lung-volume; survival; prediction; fetuses; doppler; area
dc.title A randomized controlled trial of fetal endoscopic tracheal occlusion versus postnatal management of severe isolated congenital diaphragmatic hernia
dc.type article
dc.rights.holder Copyright WILEY-BLACKWELL
dc.description.group LIM/57
dc.description.group LIM/30
dc.description.group LIM/36
dc.identifier.doi 10.1002/uog.10142
dc.identifier.pmid 22170862
dc.type.category original article
dc.type.version publishedVersion
hcfmusp.author RUANO, R.:FM:MOG
hcfmusp.author YOSHISAKI, C. T.:FM:
hcfmusp.author SILVA, M. M. da:FM:MDR
hcfmusp.author CECCON, M. E. J.:HC:ICR
hcfmusp.author TANNURI, U.:FM:MPE
hcfmusp.author ZUGAIB, M.:FM:MOG
hcfmusp.author.external · GRASI, M. S.:Univ Sao Paulo, Fac Med, Dept Neonatol, Sao Paulo, Brazil
hcfmusp.origem.id 2-s2.0-84555172118
hcfmusp.origem.id WOS:000298475600005
hcfmusp.publisher.city MALDEN
hcfmusp.publisher.country USA
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dc.description.index MEDLINE
hcfmusp.citation.scopus 127
hcfmusp.citation.wos 109
hcfmusp.affiliation.country Brasil

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