Active — Not RecruitingNot Applicable

Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Severe Left Diaphragmatic Hernia (CDH)

United States21 participantsStarted 2015-08

Plain-language summary

Despite advances in prenatal diagnosis and postnatal therapies, including extracorporeal membrane oxygenation (ECMO), inhaled nitric oxide therapy, and ventilator strategies that minimize ventilator-induced lung injury, morbidity and mortality rates for babies with congenital diaphragmatic hernia (CDH) remain high. The survival relates to the degree of prenatal lung compression and the subsequent impairment of pulmonary function following delivery. Prenatal assessment by ultrasound or magnetic resonance imaging allows to estimate the severity by relating the circumference of the lung contralateral to the hernia to the fetal head circumference lung to head ratio (LHR) and by noting the degree of upward herniation of the liver. Based on the observed to expected lung to head ratio (O/E LHR), prenatally diagnosed congenital diaphragmatic hernia can be prognostically assessed. While overall survival of congenital diaphragmatic hernia is approximately 60%, an O/E LHR \<25% is associated with survival between 11-24%. The rationale for fetal therapy in severe congenital diaphragmatic hernia is to restore adequate lung growth for neonatal survival. Prenatal tracheal occlusion obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. European colleagues have developed intrauterine endoscopic techniques (fetoscopy) to position and remove endoluminal tracheal balloons in utero (fetoscopic endotracheal occlusion = FETO). Recently, the Belgium group published summary results of FETO showing an improved survival in 175 patients with isolated left CDH from 24% to 49%. We hypothesize that FETO can be performed and may increase survival and decrease morbidity when compared to standard prenatal care for the treatment of severe CDH in the most severe group of fetuses with left CDH (O/E LHR \< 30%). FETO therapy will be considered in two subgroups: those with and O/E LHR \<25% (severe group) and those with an O/E between 25 to \<30% (less severe group).

Who can participate

Age range18 Years

SexFEMALE

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Inclusion Criteria: * Pregnant women age 18 years and older, who are able to consent. * Singleton pregnancy. * Anatomically and chromosomally normal fetus. * Left sided diaphragmatic hernia with liver up. * SEVERE pulmonary hypoplasia with O/E LHR \< 30%. * In patients with O/E LHR 25% to \<30%, enrollment prior to gestational age 30 weeks+0 days to 31 weeks+6 days. * In patients with O/E LHR \<25%, enrollment prior to gestational age 27 weeks+0 days to 29 weeks+6 days. Exclusion Criteria: * Pregnant women \< 18 years. * Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy. * Technical limitations precluding fetoscopic surgery. * Women with history of natural rubber latex allergy. * Preterm labor, cervix shortened \<15 mm within 24 hours prior to the FETO balloon insertion or uterine anomaly strongly predisposing to preterm labor, placenta previa. * Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 30%.

What they're measuring

Successful balloon insertion and removal

Timeframe: 4 to 7 weeks

Trial details

NCT IDNCT02710968

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03