[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hernia-diaphragmatic-congenital\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hernia-diaphragmatic-congenital":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100605719","prospective-registry-for-long-term-outcomes-following-feto-in-severe-left-and-right-cdh-100605719",false,"NCT07166172","Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH","North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia","Inclusion Criteria:\n\n* Pregnant women age 18 years and older\n* Singleton pregnancy\n* Normal Karyotype, chromosomal microanalysis (CMA) with non-pathologic variants, whole exome sequencing (WES) or whole genome sequencing (WGS). Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \\> 26 weeks gestation.\n* Gestational age at enrollment is prior to 29 weeks + 6 days gestation.\n* Intrathoracic liver herniation:\n\n  * Isolated left CDH with o\u002Fe LHR \\\u003C 30% at enrollment (18wks + 0 days to 29wks + 5 days gestation).\n  * Isolated right CDH with o\u002Fe LHR ≤ 45% at enrollment (18wks + 0 days to 29wks + 5 days gestation).\n* Cervical length by transvaginal ultrasound ≥ 20 mm within 24 hours prior to FETO procedure.\n* Patient meets psychosocial criteria.\n* Informed consent understood.\n\nExclusion Criteria:\n\n* Patient \\\u003C 18 years of age\n* Multi-fetal pregnancy\n* History of natural rubber latex allergy\n* Preterm labor, cervix shortened (\\\u003C20 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\n  1. Inability to reside within 30 minutes of Johns Hopkins Hospital Center for Fetal Therapy.\n  2. The patient does not have a support person (e.g., spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Johns Hopkins Hospital Center for Fetal Therapy.\n* Bilateral CDH, isolated left sided CDH with O\u002FE LHR ≥ 30% (18wks + 0 days to 29wks + 5 days gestation), isolated right sided CDH with O\u002FE LHR \\> 45% (18wks + 0 days to 29wks + 5 days gestation), as determined by ultrasound.\n* No liver herniation into thoracic cavity.\n* Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. Exclude chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., CDH and congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns).\n* Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy.\n* History of incompetent cervix with or without cerclage.\n* Placental abnormalities (previa, abruption, accreta) known at time of enrollment\n* Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.\n* Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment.\n* Uterine anomalies such as large or multiple fibroids or Mullerian duct abnormality.\n* There is 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.","FEMALE","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"NA","This registry study aims to confirm that FETO increases neonatal survival to discharge and reduces long-term morbidity in fetuses with isolated left CDH and o\u002Fe LHR \\\u003C 30%, or isolated right CDH and o\u002Fe LHR ≤ 45%, compared to those receiving standard care. This prospective registry plans to enroll 80 pregnant women (40 treatment\u002F40 control) with fetuses diagnosed with isolated CDH, and the children will be followed for up to 24 months.",[26,27,28,29,30,31,32,33],"Congenital Diaphragmatic Hernia","Congenital Abnormalities","Neonatal Diseases and Abnormalities","Hernia, DIaphragmatic, Congenital","Internal Hernia","Hernia","Pathological Conditions, Anatomical","Pathological Conditions, Signs and Symptoms",[35],"Fetoscopic Endoluminal Tracheal Occlusion","RECRUITING","2026-04-20",{"date":39,"type":40},"2026-04-23","ACTUAL",{"date":42,"type":40},"2025-06-23",{"date":44,"type":20},"2031-12-01",{"name":46,"class":47},"Johns Hopkins University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":35,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":67,"locationsCount":48},"100498548","fetoscopic-endoluminal-tracheal-occlusion-100498548","NCT05771688","Fetoscopic Endoluminal Tracheal Occlusion for Severe Left-sided Congenital Diaphragmatic Hernia","FETO","Inclusion Criteria:\n\n1. A subject is defined as a female (18 years or older) who is pregnant.\n2. The pregnancy must be a singleton pregnancy.\n3. The CDH must be left-sided.\n4. The CDH must be severe (Observed to Expected Lung to Head Ratio - O\u002FE LHR - \\\u003C 25% from U\u002FS measurements).\n5. No associated lethal anomalies (other than the CDH), no pathogenic variants on microarray, and no pathologic findings on karyotype.\n6. Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects.\n7. Gestational age at time of balloon placement between and including 27 weeks 0 days and 29 weeks 6 days.\n8. Cervix length longer than 20 mm at pre-balloon placement evaluation.\n9. Acceptance of responsibility to stay locally (within 15 minutes) of MWFCC and Children's Minnesota - Minneapolis.\n10. Written consent must be obtained.\n11. Must meet psychosocial criteria including appropriate family\u002Ffriend support during stay with balloon in place (cannot stay without additional helper), no current illicit drug use, no over-the-counter drug abuse, and no ineffectively treated DSM-IV diagnoses.\n\nExclusion Criteria:\n\n1. Twin or higher order gestation\n2. Not able to consent\n3. Right-sided or bilateral CDH\n4. Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome\n5. Maternal isoimmunization or neonatal alloimmune thrombocytopenia\n6. Balloon not able to be placed prior to 30 weeks gestation\n7. CDH O\u002FE LHR 25% or greater\n8. Maternal factors precluding safe fetal surgery (maternal cardiac findings not safe for anesthesia, maternal morbid obesity precluding safe usage of the equipment required for entry into the uterus, spontaneous preterm delivery prior to 36 weeks)\n9. Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risks of fetal transmission during procedures\n10. Short cervix (20 mm or less)\n11. History of incompetent cervix or uterine anomaly predisposing to preterm labor\n12. Significant placental abnormalities (abruption, chorioangioma, accrete) known at the time of enrollment and\u002For surgery\n13. History of natural rubber latex allergy\n14. No safe or feasible fetoscopic approach to balloon placement\n15. Inability to relocate to within 15 minutes of MWFCC\u002FChildren's Minnesota",{"count":57,"type":20},10,[23],"This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Midwest Fetal Care Center, a collaboration between Allina Health and Children's Minnesota. This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant people and their baby who meet study criteria.",[29],"2024-02-22",{"date":63,"type":40},"2024-02-23",{"date":61,"type":40},{"date":66,"type":20},"2028-09",{"name":68,"class":47},"Children's Hospitals and Clinics of Minnesota"]