[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100284706":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":38,"responsibleParty":66,"collaborators":32,"id":68,"slug":32,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":20,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":32,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":32,"overallStatus":41,"whyStopped":32,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fetal Tracheal Occlusion","EXPERIMENTAL","Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth.",[13],"Device: Fetal Tracheal Occlusion",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Fetuses with congenital diaphragmatic hernia with an observed to expected lung-to-head ratio of \\\u003C25%, LHR \\\u003C1, o\u002Fe LHR\\\u003C30% (moderate), singleton pregnancy, no known other anomalies, gestational age \\\u003C 29 weeks 6 days, no maternal disease, maternal age \\> 18 years old meet criteria to be offered tracheal occlusion. We want to test feasibility and efficacy in our center.",[9],[20,21],"FETO","Fetal Endoluminal Tracheal Occlusion",[23],{"name":24,"affiliation":25,"role":26},"Kurt Schibler, MD","CCHMC Oversight Data Safety Monitoring Committee","STUDY_CHAIR",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Foong-Yen Lim, MD","CONTACT","(513) 636-6259",null,"Foong-Yen.Lim@cchmc.org",{"name":35,"role":30,"phone":36,"phoneExt":32,"email":37},"Jose Peiro, MD, PhD","(513) 803-4563","Jose.Peiro@cchmc.org",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Cincinnati Children's Hospital Medical Center (CCHMC)","RECRUITING","Cincinnati","Ohio","45229","United States",{"type":47,"coordinates":48},"Point",[49,50],-84.51439,39.12711,{"lat":50,"lon":49},[53,56,60,63],{"name":29,"role":30,"phone":54,"phoneExt":32,"email":55},"513-803-5270","Foong.Yen.Lim@cchmc.org",{"name":57,"role":30,"phone":58,"phoneExt":32,"email":59},"Jose L Peiro, MD, PhD, MBA","513-803-4563","jose.peiroibanez@cchmc.org",{"name":61,"role":62,"phone":32,"phoneExt":32,"email":32},"Jose L Peiro, MD, MBA","SUB_INVESTIGATOR",{"name":64,"role":65,"phone":32,"phoneExt":32,"email":32},"Foong Y Lim, MD","PRINCIPAL_INVESTIGATOR",{"type":67,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100284706",false,"NCT02986087","Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia","Inclusion Criteria:\n\n* Isolated CDH with liver up\n* Severe pulmonary hypoplasia with ultrasound O\u002FE LHR \\\u003C25% at the time of surgery\n* Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days\n* Moderate pulmonary hypoplasia with ultrasound O\u002FE LHR \\\u003C30% and liver-up at the time of surgery\n* Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category\n* Maternal age greater than or equal to 18 years\n* Gestational age at enrollment prior to 29 weeks 6 days, or 31 weeks 6 days in moderate category\n* Normal karyotype or FISH\n* Normal fetal echocardiogram\n* Singleton pregnancy\n* Willing to remain in the greater Cincinnati area for remainder of pregnancy\n* Family considered and decline option of termination of the pregnancy at less than 24 weeks 0 days\n* Family meets psychosocial criteria\n\nExclusion Criteria:\n\n* Patient \\\u003C 18 years old\n* Multi-fetal pregnancy\n* Rubber latex allergy\n* Preterm labor, cervix shortened (\\\u003C15 mm) or uterine anomaly strongly predisposing to preterm labor, placenta previa\n* Bilateral CDH, isolated left sided CDH with an O\u002FE \\> 30%\n* Additional fetal anomaly by ultrasound, MRI, or echocardiogram\n* Chromosomal abnormalities\n* Maternal contraindications to fetoscopic surgery or severe maternal condition in pregnancy\n* Incompetent cervix with or without a cerclage\n* Placental abnormalities known at time of enrollment\n* Maternal HIV, Hepatits B, Hepatitis C\n* Maternal uterine anomaly\n* No safe or technically feasible fetoscopic approach to balloon placement\n* Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy",true,"FEMALE","18 Years","50 Years",{"count":78,"type":79},40,"ESTIMATED","INTERVENTIONAL",[82],"NA","Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.",[85,86,87],"Congenital Diaphragmatic Hernia","Pulmonary Hypoplasia","Pulmonary; Hypertension","2025-05-07",{"date":90,"type":91},"2025-05-11","ACTUAL",{"date":93,"type":91},"2016-11",{"date":95,"type":79},"2026-12",{"name":5,"class":6},1]