[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100249773":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":36,"studyPopulation":29,"armGroups":37,"interventions":44,"overallOfficials":51,"centralContacts":55,"locations":61,"responsibleParty":77,"collaborators":29,"id":80,"slug":29,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":29,"enrollmentInfo":89,"targetDuration":29,"studyType":92,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":63,"whyStopped":29,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Connecticut Children's Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Percent of neonatal survivors at time of discharge","Feasibility, safety, and survival rates of the FETO procedure","Discharge from the hospital, an expected average of 12 weeks.",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"Prenatal increase in lung volume","Lung volume after FETO procedure","2 weeks (prenatally)",{"measure":19,"description":20,"timeFrame":21},"Number of days of Postnatal mechanical ventilator support","mechanical ventilator support will be monitored and recorded in days of use","First 28 days of postnatal life",{"measure":23,"description":24,"timeFrame":25},"Changes in RNA content of tracheal and amniotic fluid","Describe how tracheal occlusion affects the RNA content of amniotic and tracheal fluid in CDH fetuses, and to correlate this transcriptomic profile to the degree of lung hypoplasia and fetal and neonatal clinical outcomes.","At time of balloon placement and removal",{"measure":27,"description":28,"timeFrame":25},"Characterization of extracellular vesicles (EVs) and miRNAs in tracheal and amniotic fluid","To describe how extracellular vesicles (EVs) are derived from the amniotic and tracheal fluid of CDH patients before and after tracheal occlusion, and to determine whether the identified miRNAs of interest are intra- or extra-vesicular.",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"NA","SINGLE_GROUP","TREATMENT",{"masking":35,"maskingDescription":29,"whoMasked":29},"NONE","Prenatal tracheal occlusion (TO) 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 foregut endoscopy and techniques to position and remove endoluminal tracheal balloons in utero. Recently, the Belgium group published summary results of FETO showing an improved survival in 175 patients with isolated left CDH from 24% to 49%.\n\nThe goal of this pilot study is to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH Observed\u002Fexpected lung-to-head ratio \\\u003C 25%(O\u002FE LHR \\\u003C 25%).",[38],{"label":39,"type":40,"description":41,"interventionNames":42},"Fetoscopic Endoluminal Tracheal Occlusion (FETO)","EXPERIMENTAL","An un-blinded non-randomized single arm pilot study of FETO in fetuses with congenital diaphragmatic hernia (CDH)",[43],"Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO)",[45],{"type":46,"name":39,"description":47,"armGroupLabels":48,"otherNames":49},"DEVICE","This study will position and remove an endoluminal tracheal balloon in utero (FETO) to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH and observed\u002Fexpected length head ratio \\\u003C25% (O\u002FE LHR).",[39],[50],"BALT GOLDBAL2 Tracheal Balloon Catheter system",[52],{"name":53,"affiliation":5,"role":54},"Timothy Crombleholme, MD","PRINCIPAL_INVESTIGATOR",[56],{"name":57,"role":58,"phone":59,"phoneExt":29,"email":60},"Katie E Boyle, MPH","CONTACT","860-837-6547","Kboyle01@connecticutchildrens.org",[62],{"facility":5,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"RECRUITING","Hartford","Connecticut","06106","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-72.68509,41.76371,{"lat":73,"lon":72},[76],{"name":57,"role":58,"phone":59,"phoneExt":29,"email":60},{"type":54,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Timothy Crombleholme","Director of Fetal Care Center","100249773",false,"NCT02530073","Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH","Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)","FETO","Inclusion Criteria:\n\n* Pregnant women age 18 years and older, who are able to consent\n* Singleton pregnancy\n\nFetal\n\n* Normal Karyotype\n* Fetal Diagnosis of Isolated Left CDH with liver up\n* Gestation at enrollment prior to 29 wks plus 6 days\n* SEVERE pulmonary hypoplasia with Ultra Sound O\u002FE LHR \\\u003C 25%\n\nExclusion Criteria:\n\n* Pregnant women \\\u003C18 years of age.\n* Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy\n* Technical limitations precluding fetoscopic surgery\n* Rubber latex allergy\n* Preterm labor, cervix shortened (\\\u003C15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa\n* Psychosocial ineligibility, precluding consent\n* Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O\u002FE LHR ≥ 25%\n* Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care","FEMALE","18 Years",{"count":90,"type":91},15,"ESTIMATED","INTERVENTIONAL",[31],"The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.",[96],"Congenital Diaphragmatic Hernias",[98,85,99],"congenital diaphragmatic hernia","tracheal occlusion","2026-06-16",{"date":102,"type":103},"2026-06-18","ACTUAL",{"date":105,"type":103},"2015-09",{"date":107,"type":91},"2030-08",{"name":5,"class":6},1]