[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"congenital-diaphragmatic-hernia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:congenital-diaphragmatic-hernia":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,46,76,105,127,155,191,212,242,270,296,317,342,359,390,419,441,467,502,524,547,565,586,606,625],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100637587","safety-and-efficacy-of-fetoscopic-endoluminal-tracheal-occlusion-feto-in-congenital-diaphragmatic-hernia-cdh-100637587",false,"NCT07577414","Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Congenital Diaphragmatic Hernia (CDH)","Infant Survival and Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial","FETO Intervention Arm: Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study\n* Pregnant women, age 18 years and older\n* Singleton pregnancy\n* Normal fetal karyotype, Chromosomal Microarray (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.\n* Gestational age at enrollment prior to 29w6d\n* Fetal CDH with intrathoracic liver herniation with either:\n\n  * Isolated left CDH with Observed\u002FExpected (o\u002Fe) Lung to Head Ratio (LHR) \\\u003C30% at enrollment (18w0d-29w5d)\n  * Isolated right CDH with o\u002Fe LHR \\\u003C45% at enrollment (18w0d-29w5d)\n* Cervical length by transvaginal ultrasound \\>20 mm within 24hours of FETO procedure\n* Meets psychosocial criteria\n\n  * Willing to reside within 30 minutes of Von Voigtlander Women's Hospital and ability to maintain follow up appointments\n  * Patient has a support person (e.g. spouse, partner, friend, parent) that is available to stay with participant for the duration of the pregnancy near Von Voigtlander Women's Hospital\n  * Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work (work from home approved by Principal Investigator is okay)\n\nExpectant Management Arm: Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study\n* Pregnant women, age 18 years and older\n* Singleton pregnancy\n* Normal fetal karyotype, CMA with non-pathologic variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \\>26 weeks. (non-intervention arm can have karyotype or microarray prenatally or postnatally)\n* Gestational age at enrollment prior to 29w6d\n* Fetal CDH with intrathoracic liver herniation with either:\n* Isolated left CDH with o\u002Fe LHR \\\u003C30% at enrollment (18w0d-29w5d)\n* Isolated right CDH with o\u002Fe LHR \\\u003C45% at enrollment (18w0d-29w5d)\n* Meets psychosocial criteria\n\n  * Ability to maintain follow up appointments\n\nFETO Intervention Arm: Exclusion Criteria:\n\n* Patient \\\u003C18 years of age\n* Multi-fetal pregnancy\n* History of natural rubber latex allergy\n* Preterm labor, short cervix (\\\u003C20mm within 24 hours of FETO balloon insertion procedure), or uterine anomaly strongly predisposing to preterm labor, placenta previa\n* History of incompetent cervix with or without cerclage\n* Psychosocial ineligibility\n\n  * Inability to reside within 30 minutes of Von Voigtlander Women's Hospital or inability to maintain follow up appointments\n  * Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude participant as a potential candidate (per protocol).\n* Bilateral CDH, isolated Left Congenital Diaphragmatic Hernia (LCDH) with o\u002Fe LHR \\> 30% (measured at 180 to 295 weeks), isolated Right Congenital Diaphragmatic Hernia (RCDH) with o\u002Fe LHR \\>45% (measured at 180 to 295 weeks) as determined by ultrasound\n* No liver herniation into the thoracic cavity.\n* Additional fetal anomaly or genetic\u002Fchromosomal abnormalities recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e. Fryns) by ultrasound, MRI or echocardiogram at the fetal treatment center.\n* Maternal contraindications to elective fetoscopic surgery or severe maternal medical condition in pregnancy\n* Placental abnormalities (previa, abruption, accreta) known at time of enrollment and\u002For surgery\n* Maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy\n* Maternal Human Immunodeficiency Virus (HIV), Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment\n* No safe or technically feasible fetoscopic approach to balloon placement\n* Uterine anomalies such as large fibroids or Mullerian duct abnormality\n* Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy\n\nExpectant Management Arm: Exclusion Criteria:\n\n* Patient \\\u003C18 years of age\n* Multi-fetal pregnancy\n* Preterm labor, short cervix (\\\u003C20mm), or uterine anomaly strongly predisposing to preterm labor, placenta previa\n* History of incompetent cervix with or without cerclage\n* Psychosocial ineligibility\n\n  * Inability to maintain follow up appointments\n  * Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude participant as a potential candidate.\n* Bilateral CDH, isolated LCDH with o\u002Fe LHR \\> 30% (measured at 180 to 295 weeks), isolated RCDH with o\u002Fe LHR \\>45% (measured at 180 to 295 weeks), or any isolated CDH without intrathoracic liver herniation as determined by ultrasound\n* Additional fetal anomaly or genetic\u002Fchromosomal abnormalities recognized to alter survival prognosis (i.e. congenital heart disease) or presence of an underlying genetic syndrome (i.e. Fryns) by ultrasound, Magnetic Resonance Imaging (MRI) or echocardiogram at the fetal treatment center Placental abnormalities (per protocol)\n* Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of the study is to determine if babies with left or right-sided CDH that undergo the FETO procedure survive more often and have fewer long-term complications than babies that have similar left or right-sided CDH that elect not to have the FETO procedure performed during pregnancy.",[27],"Congenital Diaphragmatic Hernia",[29,30,31,32],"Pregnant","Fetal Endoscopic tracheal occlusion","Standard of Care arm","Goldballoon Detachable Balloon (GOLDBAL2)","RECRUITING","2026-06-26",{"date":36,"type":37},"2026-06-29","ACTUAL",{"date":39,"type":37},"2026-06-17",{"date":41,"type":21},"2038-04",{"name":43,"class":44},"Dr Erin Perrone","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":17,"minAge":55,"maxAge":18,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":45},"100490504","engagement-in-physical-activities-and-sports-in-adolescents-with-diaphragmatic-hernia-100490504","NCT05666986","Engagement in Physical Activities and Sports in Adolescents With Diaphragmatic Hernia","Identification of Obstacles and Facilitators to the Engagement in Physical and Sports Activities in a Population of Adolescents Operated on for a Diaphragmatic Hernia","CHASAM","Inclusion Criteria:\n\n* Child\u002Fadolescent having undergone surgery for CDH in the first month of life, aged 12 to 18 years; absence of polypathology (i.e. diaphragmatic hernia not associated with another pathology); follow-up at the CDH reference centre, Lille site\n* Written consent from both parents allowing the collection of data from the child\u002Fadolescent\n* Written consent from the parent(s) agreeing to participate in the study by answering the questionnaires and the individual interview, for themselves and for their child\n* Possibility of accessing equipment to conduct a video-conference interview if necessary.\n\nExclusion Criteria:\n\n* Parents or child\u002Fadolescent not understanding French\n* Parents under guardianship or child under legal protection",true,"12 Years",{"count":57,"type":21},20,"OBSERVATIONAL","The objective is to understand how a population of adolescents - who have undergone diaphragm surgery within their first month of life (i.e. subjects who have been carriers of a rare impacting disease such as congenital diaphragmatic hernia (CDH)) - engages in physical and sports activities and what can be the hindering factors as well as the factors facilitating these practices.\n\nBased on self-questionnaires and semi-structured interviews, this research is a qualitative research in the field of human and social sciences.\n\nThe qualitative survey will make it possible to report on the experience of the disease of children and parents; in parallel, a complete medical evaluation of the subjects (clinical and para-clinical) will be carried out.\n\nThe analysis of the verbatim of the self-questionnaires and interviews with regard to the real physical capacities of the subjects, will be discussed.",[27],[62,63,64,65,66],"CDH","physical activity and sports","childhood and adolescence","environment sociological","psychological clinical","2026-05-20",{"date":69,"type":37},"2026-05-22",{"date":71,"type":37},"2022-05-19",{"date":73,"type":21},"2027-03",{"name":75,"class":44},"University Hospital, Lille",{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100395488","intact-cord-resuscitation-in-cdh-100395488","NCT04429750","Intact Cord Resuscitation in CDH","Efficacy of Intact Cord Resuscitation Compared to Immediate Cord Clamping on Cardiorespiratory Adaptation at Birth in Infants With Isolated Congenital Diaphragmatic Hernia (CDH)","CHIC","Inclusion Criteria:\n\n* Antenatal diagnosis of CDH\n* No severe additional malformation or chromosomal diseases\n* Full term (\\>36 weeks gestational age)\n* No inclusion in another antenatal trial\n* Written informed consents from the parents\n\nExclusion Criteria:\n\n* Preterm birth less than 37 weeks gestational age\n* Other severe malformation(s) or chromosomal diseases\n* Twin\n* Parents who may have French language understanding difficulties may not participate to the study unless they receive appropriate assistance regarding the understanding of the formal consent forms needed to get included in the study. If included in the study, regarding their French understanding level, the parents may not be proposed the auto questionnaires and interviews led by the psychologist","36 Weeks","37 Weeks",{"count":87,"type":21},180,[24],"Isolated CDH is a rare disease (1\u002F3500) and displays a wide range of severity and outcome. Despite attempts to standardize the management of this disease at birth and during the first months of life, the mortality varies from 20 to 50% according to different hospitals in France and abroad.\n\nSeveral studies already showed the benefice of late cord clamping at birth on biological and physiological adaptation of newborns to life. Previous works also suggest a possible benefit of this procedure for babies with CDH.\n\nThis multicenter randomized clinical study aims to investigate the efficacy of intact cord resuscitation compared to immediate cord clamping on cardiorespiratory adaptation at birth in full term newborn infants with isolated CDH.",[91,27],"Rare Diseases",[93,94,95,96],"Congenital diaphragmatic hernia","resuscitation","delayed cord clamping","newborn","2026-05-19",{"date":67,"type":37},{"date":100,"type":37},"2020-10-08",{"date":102,"type":21},"2026-10",{"name":75,"class":44},3,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":111,"minAge":18,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":45},"100636331","north-american-fetal-therapy-network-prospective-registry-for-long-term-outcome-following-fetoscopic-endoluminal-tracheal-occlusion-in-severe-left-and-right-congenital-diaphragmatic-hernia-100636331","NCT07564297","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* Singleton pregnancy\n* Normal fetal karyotype with confirmation by culture results, CMA with non-pathological variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \\> 26 weeks\n* Gestational age at enrollment prior to 29 6\u002F7 weeks\n* Intrathoracic liver herniation Isolated left CDH with O\u002FE LHR \\\u003C 30% at enrollment (18 0\u002F7 to 29 5\u002F7 weeks.) Isolated right CDH with O\u002FE LHR \\\u003C 45% at enrollment (18 0\u002F7 to 29 5\u002F7 weeks).\n* Cervical length by transvaginal ultrasound \\> 20 mm within 24 to 48 hours prior to FETO procedure\n* Patient meets psychosocial criteria\n* Informed consent understood\n\nExclusion Criteria:\n\n* Multi-fetal pregnancy\n* History of natural rubber latex allergy\n* Preterm labor, cervix shortened (\\\u003C20 mm at enrollment or within 24 to 48 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa\n* Psychosocial ineligibility, precluding consent:\n\n  * Inability to reside within 30 minutes of Mayo Clinic. and inability to comply with the travel for the follow-up requirements of the trial\n  * 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 Mayo Clinic.\n* Bilateral CDH, isolated left sided CDH with O\u002FE LHR 30% (measured at 180 to 295 weeks), isolated right sided CDH with O\u002FE LHR \\> 45% (measured at 180 to 295 weeks), as determined by ultrasound.\n* No intrathoracic liver herniation\n* Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns) by ultrasound, MRI, or echocardiogram at the fetal treatment center.\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 anomaly 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","50 Years",{"count":114,"type":21},80,"The purpose of this research is to determine if babies who undergo a Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure survive more often and have less long-term complications than babies who have similarly severe Congenital Diaphragmatic Hernia (CDH) that have not had the FETO procedure performed during pregnancy",[27],"NOT_YET_RECRUITING","2026-05-04",{"date":120,"type":37},"2026-05-08",{"date":122,"type":21},"2026-06-01",{"date":124,"type":21},"2038-05-31",{"name":126,"class":44},"Mayo Clinic",{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":109,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":111,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":144,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":45},"100605719","prospective-registry-for-long-term-outcomes-following-feto-in-severe-left-and-right-cdh-100605719","NCT07166172","Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH","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.",{"count":114,"type":21},[24],"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.",[27,137,138,139,140,141,142,143],"Congenital Abnormalities","Neonatal Diseases and Abnormalities","Hernia, DIaphragmatic, Congenital","Internal Hernia","Hernia","Pathological Conditions, Anatomical","Pathological Conditions, Signs and Symptoms",[145],"Fetoscopic Endoluminal Tracheal Occlusion","2026-04-20",{"date":148,"type":37},"2026-04-23",{"date":150,"type":37},"2025-06-23",{"date":152,"type":21},"2031-12-01",{"name":154,"class":44},"Johns Hopkins University",{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":17,"minAge":162,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":175,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":45},"100443196","respiratory-muscles-and-work-of-breathing-in-children-100443196","NCT05051254","Respiratory Muscles and Work of Breathing in Children","WOB&MR_Ped","Inclusion Criteria:\n\n* Patients aged less than 18 years old with primary or secondary impairment of respiratory muscles and followed at Necker Hospital\n* Patients under spontaneous breathing or noninvasive or invasive mechanical ventilation\n* Written informed consent\n\nExclusion Criteria:\n\n* No social insurance\n* Significant psychomotor retardation\n* Absence of cooperation\n* Significant agitation\n* Hemodynamic instability\n* Acute condition or temporary drug treatments that may interfere with the results of the respiratory muscle explorations","0 Years","17 Years",{"count":165,"type":21},550,[24],"Respiratory muscle testing allows a quantitative assessment of inspiratory and expiratory muscles in children of any age with primary or secondary respiratory muscle impairment, in order to better understand the pathophysiology of respiratory impairment and guide therapeutic management. The use of an invasive technique (esogastric probe) makes it possible to specifically explore the diaphragm, the accessory inspiratory muscles and the expiratory muscles in order to detect dysfunction or paralysis of these muscles, and to estimate the work of breathing in order to better guide the respiratory management.\n\nThe primary objective of the study is to evaluate the respiratory effort in children with primary or secondary impairment of the respiratory muscles during spontaneous breathing or during mechanical ventilation.",[169,27,170,171,172,173,174],"Neuromuscular Diseases","Lung Diseases","Cardiac Diseases","Scoliosis","Diaphragmatic Impairment","Respiratory Muscle Impairment",[176,177,178,179,180,181],"Respiratory muscle testing","Respiratory muscle strength","Work of breathing","Esogastric pressures","Diaphragmatic dysfunction","Diaphragmatic paralysis","2026-03-30",{"date":184,"type":37},"2026-04-03",{"date":186,"type":37},"2022-01-19",{"date":188,"type":21},"2028-01",{"name":190,"class":44},"Assistance Publique - Hôpitaux de Paris",{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":111,"minAge":18,"maxAge":112,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":45},"100513198","fetal-endoscopic-tracheal-occlusion-for-congenital-diaphragmatic-hernia-100513198","NCT05962346","Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia","Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion for Severe Left Congenital Diaphragmatic Hernia","FETO","Inclusion Criteria:\n\n* Singleton pregnancy\n* Normal fetal karyotype or microarray. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \\> 26 weeks\n* Isolated severe left CDH with O\u002FE LHR \\\u003C 25% )\n* Gestation age at enrollment prior to 29 wks plus 6 days.\n* Pulmonary hypoplasia with ultrasound O\u002FE LHR \\\u003C 25% (measured at 18 0\u002F7 to 29 5\u002F7 weeks) at the time of surgery.\n* Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound\n* Patient meets psychosocial criteria: able to reside within 30 minutes of Mayo Clinic, Rochester and able to comply with the travel for the follow-up requirements of the trial; patient has a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Mayo Clinic\n* Patient is willing and able to give informed consent\n* Appropriate multi-disciplinary counseling performed with maternal-fetal medicine, neonatology, pediatric surgery, genetics, pediatric otolaryngology (ENT)\n\nExclusion Criteria:\n\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\n* Psychosocial ineligibility, precluding consent: inability to reside within 30 minutes of Mayo Clinic, Rochester and inability to comply with the travel for the follow-up requirements of the trial; 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 Mayo Clinic\n* Right sided CDH or bilateral CDH, isolated left sided with O\u002FE LHR \\>25% measured at 18 0\u002F7 to 29 6\u002F7 weeks) as determined by ultrasound\n* Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram that will significantly worsen prognosis. No cases will be removed post hoc if abnormalities are discovered in the course of post-operative monitoring\n* Maternal contraindication to fetoscopic surgery\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.\n* Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality that will make the procedure technically unfeasible\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",{"count":57,"type":21},[24],"The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).",[27],"2026-03-17",{"date":205,"type":37},"2026-03-19",{"date":207,"type":21},"2026-12",{"date":209,"type":21},"2043-07",{"name":211,"class":44},"Mauro H. Schenone",{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":197,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":111,"minAge":18,"maxAge":112,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":222,"conditions":223,"keywords":226,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":241},"100296428","fetal-endoscopic-tracheal-occlusion-for-congenital-diaphragmatic-hernia-feto-100296428","NCT03138863","Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)","Fetal Endoscopic Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) NCT3138863","Inclusion Criteria:\n\n* Singleton pregnancy\n* Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \\> 26 weeks.\n* Isolated Left CDH with liver up\n* Gestation age at enrollment prior to 29 wks plus 6 days severe pulmonary hypoplasia with ultrasound (US) O\u002FE lung area to head circumference ratio (LHR) \\\u003C 25% (measured at 180 to 296 weeks) at the time of surgery; O\u002FE LHR 25% to \\\u003C30% (measured at 300 to 316 weeks) at time of surgery.\n* Gestational age at FETO procedure with O\u002FE LHR \\\u003C25% at 27 weeks 0 days to 29 weeks 6 days; with O\u002FE LHR 25% to \\\u003C30% at 30 weeks 0 days to 31 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound\n* Patient meets psychosocial criteria\n\nExclusion Criteria:\n\n* Multi-fetal pregnancy\n* History of natural 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* Inability to reside within 30 minute drive of our hospital, and inability to comply with the travel for the follow-up requirements of the trial\n* 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 our institution.\n* Right sided CDH or bilateral CDH, isolated left sided with O\u002FE LHR ≥30% (measured at 180 to 295 weeks) as determined by ultrasound\n* Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. No cases will be removed post hoc if abnormalities are discovered in the course of postoperative monitoring\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, accrete) 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 Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality\n* Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy",{"count":220,"type":21},10,[24],"The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).",[27,224,225],"Pulmonary Hypoplasia","Pulmonary Artery Hypertension",[227,228,229,230,231],"fetal lungs","fetal surgery","congenital diaphragmatic hernia","tracheal occlusion","pulmonary hypoplasia","2026-02-19",{"date":234,"type":37},"2026-02-23",{"date":236,"type":37},"2024-05-01",{"date":238,"type":21},"2030-11-01",{"name":240,"class":44},"Rodrigo Ruano",2,{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":17,"minAge":249,"maxAge":250,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":255,"conditions":256,"keywords":257,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":269},"100455677","phase-4-de-implementing-inhaled-nitric-oxide-for-congenital-diaphragmatic-hernia-100455677","NCT05213676","De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia","Inhaled Nitric Oxide (iNO) for Congenital Diaphragmatic Hernia (CDH) - The \"NoNO Trial\" - a Multi-center, De-implementation, Stepped-wedge, Cluster-randomized Trial Within an Established Collaborative","Inclusion Criteria:\n\n* Postnatal, live born neonates with CDH\n\n  a. Presence of associated or additional anomalies is acceptable for inclusion\n* Bochdalek hernia location (right or left)\n* Diagnosed prior to 1 month of life\n* Born within or transferred to (within 1 week of life) a CDHSG member center participating in the trial\n\nExclusion Criteria:\n\n* CDH diagnosis after 1 month of age\n* Morgagni diaphragmatic hernia (central \u002F anterior-medial diaphragmatic defect location)\n* Transferred to a CDH Study Group (CDHSG) member center after 1 week of life\n* Patients without potential access to iNO","0 Months","1 Month",{"count":252,"type":21},600,[254],"PHASE4","The purpose of this study is to determine if de-implementation of inhaled nitric oxide (iNO) in the post-natal resuscitation\u002Fstabilization phase affects the composite outcome of extracorporeal life support (ECLS) use and\u002For mortality, as well as ECLS use, mortality, and\u002For oxygenation in congenital diaphragmatic hernia (CDH) newborns and to establish the cost-effectiveness of de-implementing iNO as a therapy in the postnatal resuscitation\u002Fstabilization phase of CDH management, which will be assessed as the incremental health system costs (savings) per prevented ECLS use and\u002For death.",[27],[62,258,259],"Inhaled Nitric Oxide","Pulmonary Hypertension","2026-02-04",{"date":262,"type":37},"2026-02-09",{"date":264,"type":37},"2025-11-01",{"date":266,"type":21},"2031-04-30",{"name":268,"class":44},"The University of Texas Health Science Center, Houston",19,{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":111,"minAge":18,"maxAge":277,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":279,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":45},"100361020","fetal-endotracheal-occlusion-feto-in-the-resolution-of-pulmonary-hypertension-in-fetuses-with-severe-cdh-100361020","NCT03980717","Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension in Fetuses With Severe CDH","A Prospective Study on the Role of Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension Among Fetuses With Severe Congenital Diaphragmatic Hernia","Inclusion Criteria:\n\n* Patient is a pregnant woman between 18 and 45 years of age\n* Singleton pregnancy\n* The fetuses will be 28+0\u002F7 to 31+6\u002F7 weeks of gestational age\n* Confirmed diagnosis of severe left- or right-sided CDH of the fetus: Observed\u002Fexpected total lung volume equal to or less than 0.32 with more than 21% of liver herniated into the hemithorax. (Ideally calculated between 28+0\u002F7 and 31+6\u002F7 weeks' gestation.)\n* Normal fetal echocardiogram or echocardiogram with a minor anomaly (such a small VSD) that in the opinion of the pediatric cardiologist will not affect postnatal outcome\n* Normal fetal karyotype or microarray\n* The mother must be healthy enough to have surgery\n* Patient and father of the baby provide signed informed consent that details the maternal and fetal risks involved with the procedure\n* Patient willing to remain in Houston for the duration following balloon placement until delivery.\n\nExclusion Criteria:\n\n* Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia\n* Allergy to latex\n* Allergy or previous adverse reaction to a study medication specified in this protocol\n* Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy.\n* Fetal aneuploidy, known structural genomic variants, other major fetal anomalies that may impact the fetal\u002Fneonatal survival or known syndromic mutation\n* Suspicion of major recognized syndrome (e.g. Fryns syndrome) on ultrasound or MRI\n* Maternal BMI \\>40\n* High risk for fetal hemophilia","45 Years",{"count":114,"type":21},[24],"Congenital diaphragmatic hernia (CDH) occurs when the diaphragm fails to fully fuse and leaves a portal through which abdominal structures can migrate into the thorax. In the more severe cases, the abdominal structures remain in the thoracic cavity and compromise the development of the lungs. Infants born with this defect have a decreased capacity for gas exchange; mortality rates after birth have been reported between 40-60%. Now that CDH can be accurately diagnosed by mid-gestation, a number of strategies have been developed to repair the hernia and promote lung tissue development.\n\nFetal tracheal occlusion (FETO), using a fetoscopically delivered and removed balloon device, has been used to temporarily occlude the trachea and increase lung distension in CDH to allow the lungs to develop and has been shown to increase survival at birth. The role of FETO in the resolution of pulmonary hypertension in fetuses with severe left- and right- sided CDH remains unclear. Our recent observation that FETO is associated with a higher proportion of infants who resolve their pulmonary hypertension by the age of 1 year as compared with those who have not had FETO, is based on a retrospective cohort study, which, as with any such design, has some intrinsic limitations. Thus, a prospective cohort study that is appropriately powered to confirm or disprove this encouraging observation is needed. If our preliminary observation is confirmed, resolution of PH by the age of 1 year could be added to the benefits of the FETO procedure in severe left and right-sided CDH cases.\n\nThe investigators will perform 40 FETO procedures on fetuses diagnosed prenatally with severe right- or left-sided CDH, and outcome data will be compared with that of a control group of severe right- or left-sided CDH who will not undergo the FETO procedure because of medical or social issues. Because the prevalence of left-sided CDH is higher than right-side CDH, the investigators will perform 25 FETO procedures in left sided CDH and 15 in right-sided CDH, and these outcomes will be compared to a cohort of 40 non FETO cases.",[27],[283,284,285,286,287,197],"Fetal Tracheal Occlusion","FETO plug-unplug","Goldvalve balloon","Severe Congenital Diaphragmatic Hernia","Goldbal balloon",{"date":289,"type":37},"2026-02-06",{"date":291,"type":37},"2019-08-09",{"date":293,"type":21},"2030-12",{"name":295,"class":44},"Michael A Belfort",{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":197,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":111,"minAge":18,"maxAge":112,"enrollmentInfo":303,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":45},"100474693","fetal-endoscopic-tracheal-occlusion-feto-for-severe-congenital-diaphragmatic-hernia-100474693","NCT05461222","Fetal Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia","A Study of the Effectiveness of Fetal Endoscopic Tracheal Occlusion (FETO) in the Management of Severe Prenatally Diagnosed Congenital Diaphragmatic Hernia (CDH)","Inclusion Criteria:\n\n* Maternal Age: 18-50\n* Singleton gestation\n* Gestational age before 29 weeks 6 days\n* Severe left or right-sided CDH: For severe left sided CDH observed-to-expected lung-to- head ratio (o\u002Fe LHR) less than 25% between 22 and 29 6\u002F7 weeks' gestation, liver herniation, MRI lung volumes less than 30% expected based on gestational age nomograms. For severe right sided CDH o\u002Fe LHR less than 30 % between 22 and 29 6\u002F7 weeks' gestation, liver herniation, MRI lung volumes less than 30% expected based on gestational age nomograms.\n* Normal genetic karyotype or microarray testing by amniocentesis or chorionic villus sampling (CVS)\n* Absence of associated fetal structural cardiac anomalies by a dedicated fetal echocardiogram\n* Absence of other structural anomalies by ultrasound or MRI\n* Appropriate multi-disciplinary counseling performed with maternal-fetal medicine, neonatology, pediatric surgery, genetics, pediatric otolaryngology (ENT).\n* Must be willing to remain near LPCH Stanford (within 30 minutes from the hospital) for the duration of the balloon placement.\n* No maternal and\u002For fetal contra-indications to fetal surgery such as a bleeding disorder, poorly controlled diabetes or hypertension, short cervix (measuring \\\u003C 20mm), risk for preterm birth etc.\n* Planned pregnancy surveillance at LPCH Stanford\n* Planned delivery at LPCH Stanford\n* Able to provide written consent\n* Willingness to comply with all study procedures and availability (meets psychosocial criteria) for the duration of the study including having a support person\n\nExclusion Criteria:\n\n* Contraindications to fetal surgery including poorly controlled hypertension, diabetes or other maternal medical condition including hematological disorder\n* High risk for preterm labor and\u002For delivery based on either significant history of preterm birth, short cervix (measuring \\\u003C 20mm), significant uterine anomaly or other risk factor, incompetent cervix (requiring cerclage)\n* Non-isolated CDH - CDH with additional structural anomalies\n* Significant maternal obesity defined as a body mass index (BMI) greater than 40. BMI is a calculation which includes a person's height and weight\n* History of natural rubber latex allergy\n* Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality\n* Participation in another intervention study that influences maternal and fetal morbidity and mortality.\n* Bilateral CDH, left-sided CDH with O\u002FE LHR \\>25%, or left-sided CDH with O\u002FE LHR \\\u003C25% but liver completely down in abdomen\n* Right-sided CDH O\u002FE LHR \\>30% or right-sided CDH with O\u002FE LHR \\\u003C30% with liver completely down in abdomen\n* Significant placental abnormalities (abruption, chorioangioma, accreta) known at the time of enrollment and\u002For surgery\n* Maternal-fetal Rhesus isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia, affecting the current pregnancy.\n* Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure\n* No safe or feasible fetoscopic approach to balloon placement.",{"count":304,"type":21},15,[24],"The purpose of the study is to study the efficacy of fetal endoscopic tracheal occlusion (FETO) in cases of severe congenital diaphragmatic hernia (CDH). This study will also collect safety and effectiveness data for the off-label use of the FETO Goldballoon (the balloon that will be inserted into the fetal trachea), manufactured by Balt medical. The investigators hope to study the risks and benefits of FETO in cases of severe CDH in an advanced medical center such as Lucile Packard Children's Hospital (LPCH) Stanford with access to advanced maternal-fetal medicine, neonatal services, and neonatal ECMO, and pediatric surgery.",[27],"2026-01-27",{"date":310,"type":37},"2026-01-29",{"date":312,"type":37},"2023-04-17",{"date":314,"type":21},"2030-08-31",{"name":316,"class":44},"Yair Blumenfeld",{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":197,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":111,"minAge":18,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":22,"phases":325,"briefSummary":326,"conditions":327,"keywords":328,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":45},"100473881","trial-of-feto-for-severe-congenital-diaphragmatic-hernia-100473881","NCT05450653","Trial of FETO for Severe Congenital Diaphragmatic Hernia","Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia (CDH)","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Pregnant individuals age 18 years and older\n* Singleton pregnancy\n* No pathogenic variants on prenatal chromosomal microarray or pathologic findings on karyotype analysis. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \\> 26 weeks\n* Isolated left CDH with severe pulmonary hypoplasia with o\u002Fe LHR \\\u003C\u002F=25% with liver up (measured at 18 weeks 0 days to 29 weeks 5 days of gestation) OR Isolated right CDH with severe pulmonary hypoplasia with o\u002Fe LHR \\\u003C\u002F=35% with liver up (measured at 18 weeks 0 days to 29 weeks 5 days of gestation)\n* Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by clinical information and evaluation of first ultrasound\n* Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects\n* Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study\n\n  * Willingness to reside within 30 minutes of the Chicago Institute for Fetal Health (CIFH) in the time period between the FETO placement procedure and the balloon retrieval procedure and ability to maintain follow up appointments\n  * Subject has a support person (e.g., spouse, partner, friend, parent) that is available to stay with her for the duration of the pregnancy near Lurie Children's\n  * Willingness to comply with study restrictions on work, exercise, and intercourse\n* Meets psychosocial criteria\n\nExclusion Criteria:\n\n* Rubber latex allergy\n* Presence of chromosomal abnormalities or anatomic anomalies that are known to significantly alter survival prognosis (i.e., CDH and congenital heart disease). No cases will be removed post hoc if abnormalities are discovered during post-operative monitoring\n* History of preterm labor, cervix shortened to ≤20 mm at enrollment or at 24 hours prior to FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor or placenta previa\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, chorioangioma) 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 anomaly 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\n* Any other condition which, in the opinion of the investigator, would compromise safety, feasibility or impede compliance",{"count":220,"type":21},[24],"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 Ann \\& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's). This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant women who meet study criteria.",[27],[329,330,145,29,331,332],"Hernia, Diaphragmatic, Congenital","Fetal Endoscopic Tracheal Occlusion","Humans","Fetoscopy","2026-01-26",{"date":335,"type":37},"2026-01-28",{"date":337,"type":37},"2022-09-18",{"date":339,"type":21},"2031-11",{"name":341,"class":44},"Aimen F. Shaaban, MD",{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":54,"sex":111,"minAge":18,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":22,"phases":349,"briefSummary":350,"conditions":351,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":45},"100407301","pilot-trial-of-fetoscopic-endoluminal-tracheal-occlusion-feto-in-severe-left-congenital-diaphragmatic-hernia-cdh-100407301","NCT04583644","Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)","Inclusion Criteria:\n\n* Pregnant women age 18 years and older\n* Singleton pregnancy\n* Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \\> 26 weeks\n* Isolated Left CDH with liver up\n* Gestation age at enrollment prior to 29 wks plus 6 days\n* SEVERE pulmonary hypoplasia with US LHR O\u002FE \\\u003C 25% (measured at 180 to 295 weeks) at the time of surgery\n* Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound\n* Family meets psychosocial criteria\n* Pre-authorization from third-party payor for fetal intervention OR the ability to self-pay for study treatment. For all patients without insurance or the means to pay for the procedure, an attempt will be made to obtain Medicaid. Insurers that have denied payment have noted that this remains an experimental procedure. As this is a feasibility study and not being offered as either standard of care or as a prospective randomized control trial to determine efficacy, the investigators do not feel that there is a breach of ethical standards.\n* Informed consent\n\nExclusion Criteria:\n\n* Failure to meet all inclusion criteria\n* Patient \\\u003C 18 years of age\n* Multi-fetal pregnancy\n* Rubber latex allergy\n* Preterm labor, cervix shortened (\\\u003C 15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa\n* Family does not meet psychosocial criteria. Reasons for exclusion include: insufficient social support, inability to understand requirements of the study, inability to reside in or near San Francisco.\n* Right sided CDH or bilateral CDH, isolated left sided with LHR O\u002FE \\\u003C 25% (measured at 180 to 295 weeks) as determined by ultrasound\n* Additional fetal anomaly by ultrasound, MRI, or echocardiogram at the fetal treatment center. Exclude chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (ie. CDH and congenital heart disease) or presence of an underlying genetic syndrome (ie. Fryns). No cases will be removed post hoc if abnormalities are discovered in the course of post-operative monitoring\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, accrete) 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 anomaly 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",{"count":220,"type":21},[24],"Despite advances in prenatal diagnosis and postnatal therapies, including ECMO (Extracorporeal Membrane Oxygenation), inhaled nitric oxide therapy, and ventilator strategies that minimize ventilator-induced lung injury, morbidity and mortality rates for babies with severe CDH remain high. The rationale for fetal therapy in severe CDH is to promote 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. The investigator's goal with this pilot study is to study the feasibility of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with left CDH (LHR O\u002FE \\\u003C 25%).",[27],{"date":335,"type":37},{"date":354,"type":37},"2020-10-02",{"date":356,"type":21},"2028-04",{"name":358,"class":44},"Hanmin Lee",{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":54,"sex":17,"minAge":366,"maxAge":367,"enrollmentInfo":368,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":370,"conditions":371,"keywords":376,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":45},"100620981","measuring-heart-health-in-both-term-preterm-and-unwell-newborn-babies-with-an-advanced-ultrasound-method-speckle-tracking-echocardiography-100620981","NCT07364682","Measuring Heart Health in Both Term, Preterm and Unwell Newborn Babies With an Advanced Ultrasound Method: Speckle Tracking Echocardiography","Assessment of Cardiac Function Using 2D Speckle Tracking Echocardiography (STE) in Neonates.","Inclusion Criteria:\n\n* Neonates who are inpatient at the Birmingham Women's Hospital\n* Confirmed diagnosis of acute pulmonary hypertension, congenital diaphragmatic hernia, hypoxic ischaemic encephalopathy, or bronchopulmonary dysplasia\u002Fchronic lung disease (defined by oxygen\u002Frespiratory support requirement at 36 weeks post menstrual\u002Fcorrected gestational age).\n\nOR\n\n* Health control (\\>36 weeks - well and on the postnatal ward)\n* Well preterm neonate (\\\u003C36 weeks) admitted to the NICU, transitional care or post-natal wards.\n* Informed consent obtained from parent(s) or legal guardian(s)\n\nExclusion Criteria:\n\n* Presence of major congenital heart disease (other than patent foramen ovale or patent ductus arteriosus).\n* Presence of other life-limiting congenital anomalies (other than CDH) or syndromes that could independently affect cardiac function.\n* Inability to obtain adequate echocardiographic images for STE analysis after reasonable attempts.\n* If the neonatal consultant or neonatal nurse caring for the neonate feels that the neonate is too unstable for inclusion in the study or that consent should not be sought from parents.","0 Minutes","8 Weeks",{"count":369,"type":21},190,"This study aims to improve how neonatologists check the heart function of newborn babies, especially those who are sick. While standard heart ultrasound scans are useful, a more advanced and sensitive technique called 2D speckle tracking echocardiography (STE) can detect subtle problems with how the heart muscle squeezes and relaxes. This may allow doctors to spot potential issues earlier.\n\nOur research will take place at Birmingham Women's Hospital. The investigators will perform these advanced, non-invasive heart scans on several groups of babies:\n\n1. Healthy term and premature babies, to establish a \"normal\" range of heart function.\n2. Babies who are unwell with specific conditions, including those with brain injury due to lack of oxygen at birth (HIE), chronic lung disease of prematurity (BPD), a hole in the diaphragm (CDH), or high blood pressure in their lungs (aPHN).\n\nThe heart scan is a standard, painless procedure. Using STE does not require any extra scanning time or cause any additional discomfort to the baby; the special images are taken during the routine scan. For many of the sick babies, these scans are already part of their normal clinical care.\n\nThe main goals of this observational study are to see if STE is a feasible and reliable tool in newborns, to establish normal values for healthy babies, and to track how heart function changes in sick babies during their illness and recovery.\n\nUltimately, the investigators hope this research will provide doctors with a better tool to assess heart health in newborns. This could lead to earlier, more accurate detection of heart problems and help guide treatment decisions to improve outcomes for these vulnerable infants.",[372,373,374,27,375],"Premature Baby","Pulmonary Hypertension of Newborn","Hypoxic Ischaemic Encephalopathy (HIE)","Chronic Lung DIsease",[377,378,379,380],"Speckle Tracking Echocardiography","STE","Functional echocardiography","Neonatal Performed Echocardiography","2026-01-23",{"date":333,"type":37},{"date":384,"type":21},"2026-02-01",{"date":386,"type":21},"2028-03-01",{"name":388,"class":389},"Birmingham Women's NHS Foundation Trust","OTHER_GOV",{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":54,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":399,"conditions":400,"keywords":401,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":418},"100129184","diaphragmatic-hernia-research--exploration-advancing-molecular-science-100129184","NCT00950118","Diaphragmatic Hernia Research & Exploration, Advancing Molecular Science","DHREAMS","Inclusion Criteria:\n\n* All individuals affected with a congenital diaphragmatic hernia (CDH), or with a family history of a CDH\n\nExclusion Criteria:\n\n* Individuals with no personal history of a CDH or family history of a family member affected with congenital diaphragmatic hernia",{"count":398,"type":21},3000,"The goal of this study is to identify genes that convey susceptibility to congenital diaphragmatic hernia in humans. The identification of such genes, and examination of their structure and function, will enable a delineation of molecular pathogenesis and, ultimately, prevention or treatment of congenital diaphragmatic hernia. There are many different possible modes of inheritance for congenital anomalies, including autosomal dominant, autosomal recessive, and multifactorial. Multi-factorial inheritance is responsible for many common medical disorders, including hypertension, myocardial infarction, diabetes and cancer. This type of inheritance pattern appears to involve environmental factors as well as a combination of genetic variations that together can predispose to or produce congenital anomalies, such as congenital diaphragmatic hernia.\n\nOur study is designed to establish a small, well-defined genetic resource consisting of 1) Nuclear families suitable for linkage analysis by parametric,non-parametric (e.g. sib pairs, TDT) and association techniques, 2) Individuals with congenital diaphragmatic hernia who can be directly screened for allelic variation in candidate genes, and 3) Individuals who can serve as controls (are unaffected by congenital diaphragmatic hernia). Neonates and their families will be collected from homogenous and heterogeneous populations. By characterizing diverse populations, it should be possible to increase the likelihood of demonstration of genetic variation in selected candidate genes that can then be used in association and linkage studies in individual subjects with congenital diaphragmatic hernia.",[27],[402,403,404,405,406,407,408],"Congenital Diaphragmatic Hernia (CDH)","Genes","Genetic","Genetic testing","exome sequencing","genome sequencing","RNAseq","2025-12-08",{"date":411,"type":37},"2025-12-12",{"date":413,"type":4},"2005-06",{"date":415,"type":21},"2026-09",{"name":417,"class":44},"Columbia University",14,{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":197,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":111,"minAge":18,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":22,"phases":427,"briefSummary":428,"conditions":429,"keywords":430,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":45},"100471653","fetal-endoscopic-tracheal-occlusion-for-cdh-cdh-100471653","NCT05421676","Fetal Endoscopic Tracheal Occlusion for CDH (CDH)","Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study\n3. Pregnant women, age 18 years and older\n4. Singleton pregnancy\n5. No pathogenic variants on microarray or pathologic findings on karyotype\n6. Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects\n7. Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as o\u002Fe LHR \\\u003C25% with liver up\n8. Gestational age at FETO procedure: if o\u002Fe LHR \\\u003C25% will be done at 27 weeks plus 0 days to 29 weeks plus 6 days\n9. Meets psychosocial criteria\n\n   * Willing to reside within 30 minutes of UC Davis Medical Center and ability to maintain follow up appointments\n   * Patient has a support person (e.g. spouse, partner, friend, parent) that is available to stay with her for the duration of the pregnancy near the UC Davis Medical Center.\n   * Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work\n\nExclusion Criteria:\n\n1. Adults unable to consent\n2. Prisoners\n3. Multi-fetal pregnancy\n4. History of latex allergy\n5. History of preterm labor or incompetent cervix (requiring cerclage), short cervix (\\\u003C20mm), or uterine anomaly predisposing to preterm labor\n6. Psychosocial ineligibility\n\n   * Inability to reside within 30 minutes of UC Davis Medical Center or inability to maintain follow up appointments\n   * Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude her as a potential candidate.\n7. Bilateral CDH, unilateral CDH with o\u002Fe LHR \\> 25% or unilateral CDH with o\u002Fe LHR \\\u003C25% but liver completely down in abdomen\n8. Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome\n9. Maternal contraindications to elective fetoscopic surgery\n10. Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and\u002For surgery\n11. Maternal isoimmunization or neonatal alloimmune thrombocytopenia\n12. Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure\n13. No safe or feasible fetoscopic approach to balloon placement",{"count":220,"type":21},[24],"This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at UC Davis Medical Center. The study will enroll pregnant women that meet study criteria. Participants will have placement of FETO between gestational age at 27 weeks plus 0 days and 29 weeks 6 days. The timing for removal of FETO will ideally be between 34 weeks 0 days and 34 weeks and 6 days but ultimately decided by the Fetal Diagnosis and Treatment Center at UC Davis Medical Center.\n\nThis study requires that study participants live within 30 minutes of the UC Davis Medical Center in order to maintain weekly follow up appointments while the balloon is in place and up to delivery. Additionally, there are lifestyle considerations where participants would be unable to carry on normal daily activities including exercise and sexual intercourse, not be able to work the remainder of the pregnancy, as well as have a support person that is available to stay with such as a spouse, friend, partner, parent.",[27],[27,431],"Fetal endoscopic tracheal occlusion","2025-12-05",{"date":434,"type":37},"2025-12-15",{"date":436,"type":37},"2024-02-12",{"date":438,"type":21},"2027-12",{"name":440,"class":44},"University of California, Davis",{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":447,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":17,"minAge":449,"maxAge":450,"enrollmentInfo":451,"targetDuration":4,"studyType":22,"phases":452,"briefSummary":453,"conditions":454,"keywords":455,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":466},"100611950","phase-4-efficacy-of-inhaled-nitric-oxide-in-congenital-diaphragmatic-hernia-100611950","NCT07247240","Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia","Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia With Early Pulmonary Hypertension","INOCDH","Inclusion Criteria:\n\n* Bochdalek type congenital diaphragmatic hernia\n* Gestational age at 34 weeks or more and within 14 days after birth\n* Hypoxic respiratory failure and pulmonary hypertension\n\nExclusion Criteria:\n\n* Combined congenital heart disease requiring neonatal intervention or surgery\n* Previous treatment of pulmonary vasodilators including inhaled nitric oxide\n* on ECMO treatment","1 Minute","14 Days",{"count":20,"type":21},[254],"This multicenter, prospective, single-arm study aims to evaluate the efficacy of inhaled nitric oxide (iNO) in neonates with congenital diaphragmatic hernia (CDH) and early pulmonary hypertension. Short-term treatment response will be assessed by the changes in oxygenation index and other parameters including echocardiographic parameters at predefined intervals.",[27,259],[27,456,259],"Nitric Oxide","2025-11-23",{"date":459,"type":37},"2025-11-25",{"date":461,"type":21},"2025-11",{"date":463,"type":21},"2028-12",{"name":465,"class":44},"Asan Medical Center",4,{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":475,"enrollmentInfo":476,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":478,"conditions":479,"keywords":485,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":241},"100572329","an-exploratory-physiological-study-of-post-operative-recovery-in-surgical-neonates-and-dimethylargininearginine-levels-100572329","NCT06731855","An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels","An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels (SuNDiAL)","SuNDiAL","Inclusion Criteria:\n\n1. Infants born \\>35 weeks gestation\n2. Have a condition requiring major gastrointestinal surgery\n3. Surgery within the first 5 days (120 hours) following birth (including congenital diaphragmatic hernia who are stable enough for surgery in this time frame).\n4. Parent(s)\u002Fguardian(s) must have a comprehensive understanding of written and spoken English, sufficient to provide informed using the translation services available to the research team.\n5. Must be willing and able to provide informed consent in order to take part in the study\n\nExclusion Criteria:\n\n1. Infants who are unlikely to survive because of poor immediate postoperative condition.\n2. Infants known (or suspected to have) a diagnosis of inborn error of metabolism or serious liver dysfunction.\n3. Parent(s)\u002Fguardian(s) who are unable to give informed consent.\n4. Infants who it is not possible to obtain the minimum required residual serum samples from routine biochemical blood testing as outlined in the study schedule","5 Days",{"count":477,"type":21},30,"The SuNDiAL study will measure levels of two naturally occurring amino acids: Arginine and Asymmetric Dimethylarginine (ADMA) in neonates undergoing abdominal surgery in the first 5 days of life due to congenital abdominal malformations as the participants recover from surgery.\n\nThe investigators hypothesise that the relationship between Arginine and ADMA may be useful in predicting recovery and complications in babies who have had abdominal surgery due to previous research published in adult patients undergoing abdominal surgery. If this relationship is found to be useful there may be options for developing treatments (such as arginine supplementation) in the future to improve recovery and reduce complications in neonates undergoing abdominal surgery.\n\nNeonates born after 35 weeks gestation who have a congenital abdominal malformation who require abdominal surgery in the first 5 days will be eligible to participate in the SuNDiAL study.\n\nArginine and ADMA will be measured from blood samples that are left over from the participant's blood tests that are taken as part of their routine clinical care. The investigators will measure Arginine and ADMA preoperatively and at least 10 points in the 30 days following their surgery, or until the participant fully recovers from surgery (which ever comes first). There is no intervention in the SuNDiAL study, and there will be no extra blood or blood samples taken.\n\nSerums samples that are left over from the babies routine clinical blood tests will be stored securely in the hospitals laboratory until analysis for Arginine and ADMA.\n\nThe levels of Arginine and ADMA will be compared to the time it takes the participants to recover from surgery and any complications that may arise following surgery. During the study the study team will use the participants electronic medical record to establish when the participant became fully established on oral feeding and monitor for any complications that occurred during their recovery.",[480,27,481,482,483,484],"Gastroschisis","Duodenal Atresia","Oesophageal Atresia With Tracheo-Oesophageal Fistula","Oesophageal Atresia","Exomphalos",[486,487,488,489,490,491,492],"Neonatal","Abdominal Surgery","Asymmetric Dimethylarginine","ADMA","Arginine","Recovery","Neonate","2025-09-24",{"date":495,"type":37},"2025-09-29",{"date":497,"type":37},"2024-02-05",{"date":499,"type":21},"2026-02",{"name":501,"class":44},"Liverpool Women's NHS Foundation Trust",{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":506,"acronym":507,"eligibilityCriteria":508,"healthyVolunteers":54,"sex":111,"minAge":18,"maxAge":112,"enrollmentInfo":509,"targetDuration":4,"studyType":22,"phases":511,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":45},"100607334","phase-3-safety-and-efficacy-of-feto-in-cdh-phase-iii-100607334","NCT07187206","Safety and Efficacy of FETO in CDH Phase III","CDH FETO","Inclusion Criteria:\n\n* Pregnant women 18 years and older, who are able to consent\n* Singleton pregnancy\n* Gestational age at enrollment is prior to 296 weeks\n* Intrathoracic liver herniation\n* Isolated Left CDH with o\u002Fe LHR \\\u003C 30% at enrollment (180 to 295 weeks) or\n* Isolated Right CDH with o\u002Fe LHR \\\u003C 45% at enrollment (180 to 295 weeks)\n* Normal fetal karyotype with confirmation by culture results, CMA with non-pathological variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \\> 26 weeks\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 (\\\u003C 20 mm at enrollment or within 24 hours prior to FETO balloon insertion) or uterine anomaly strongly predisposing to preterm labor, or placenta previa.\n* Psychosocial ineligibility, precluding consent:\n\n  * Inability to reside within 30 minutes of Cincinnati Children's Hospital Medical Center and inability to comply with the travel for the follow-up requirements of the trial.\n  * 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 Cincinnati Children's Hospital Medical Center.\n* Bilateral CDH, isolated LCDH with o\u002Fe LHR ≥ 30%, isolated RCDH with o\u002Fe LHR \\> 45%, as determined by ultrasound.\n* No liver herniation into thoracic cavity\n* Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns) by ultrasound, MRI, or echocardiogram at the fetal treatment center.\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 positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV status is unknown, the patient must be tested and found to have negative results before enrollment.\n* Positive Hepatitis B surface antigen or presence of Hepatitis C in maternal blood uterine anomaly such as Mullerian duct abnormality, large or multiple fibroids that prohibit safe fetoscopic procedure\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",{"count":510,"type":21},75,[512],"PHASE3","Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group",[27,224,259],"2025-09-16",{"date":517,"type":37},"2025-09-22",{"date":519,"type":21},"2025-09-30",{"date":521,"type":21},"2033-03-01",{"name":523,"class":44},"Children's Hospital Medical Center, Cincinnati",{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":111,"minAge":18,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":22,"phases":532,"briefSummary":533,"conditions":534,"keywords":535,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":45},"100588835","phase-3-safety-and-efficacy-of-fetoscopic-endoluminal-tracheal-occlusion-in-congenital-diaphragmatic-hernia-100588835","NCT06946576","Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion in Congenital Diaphragmatic Hernia","Infant Survival and Long-term Outcomes Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial","Inclusion Criteria:\n\n* Pregnant person age 18 years or older\n* Singleton pregnancy\n* Normal fetal karyotype with confirmation by culture results, Chromosomal Microarray (CMA) with non-pathological variants, Whole Exome Sequencing (WES) or Whole Genome Sequencing (WGS). Results by florescence in situ hybridization (FISH) will be acceptable if the patient is \\>26 weeks gestation\n* Gestational age at enrollment less than 29 weeks 6 days\n* Intrathoracic liver herniation\n* Isolated left Congenital Diaphragmatic Hernia (CDH) with Lung to Head Circumference Ratio (LHR) \\\u003C30% at enrollment OR isolated right CDH with LHR \\\u003C= 45% at enrollment\n* Cervical length by transvaginal ultrasound \\>= 20 mm within 24 hours of FETO procedure\n* Psychosocial criteria\n* Able to provide informed consent\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 or placenta previa\n* Psychosocial ineligibility precluding consent\n* Inability to reside within 30 minutes of OHSU\n* Inability to comply with the travel for the follow-up requirements of the trial\n* Lack of a support person (e.g., spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at OHSU.\n* Bilateral CDH, isolated left sided CDL with LHR \\>= 30% or isolated right side CDH with LHR \\>45% as determined by ultrasound\n* No intrathoracic liver herniation\n* Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e. congenital heart disease) or presence of an underlying genetic syndrome (i.e. Fryns) by ultrasound, MRI, or echocardiogram at the fetal treatment center\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 anomaly such as large or multiple fibroids or Mullerian duct abnormality\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.",{"count":114,"type":21},[512],"The purpose of this study is to evaluate the safety and efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in cases of severe Congenital Diaphragmatic Hernia (CDH).",[27],[536,537],"Fetal Surgery","Fetoscopic Endoluminal Tracheal Occlusion (FETO)","2025-08-25",{"date":540,"type":37},"2025-09-02",{"date":542,"type":21},"2025-09",{"date":544,"type":21},"2030-04",{"name":546,"class":44},"Oregon Health and Science University",{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":109,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":111,"minAge":18,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":555,"conditions":556,"keywords":557,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":564,"locationsCount":45},"100572906","north-american-fetal-therapy-network-for-long-term-outcome-following-fetoscopic-endoluminal-tracheal-occlusion-in-severe-left-and-right-congenital-diaphragmatic-hernia-100572906","NCT06739356","North American Fetal Therapy Network for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia","Inclusion Criteria:\n\n* Pregnant women who are able to consent\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\n* Gestational age at enrollment is prior to 296 wks.\n* Intrathoracic liver herniation\n* Isolated left CDH with o\u002Fe LHR \\\u003C 30% at enrollment (180 to 295 wks.). or\n* Isolated RCDH with o\u002Fe LHR \\\u003C 45% at enrollment (180 to 295 wks.)\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* 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 University of Texas Health Science Center at Houston Fetal Center\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 UTHealth Houston Fetal Center\n* Bilateral CDH, isolated left sided CDH with O\u002FE LHR ≥ 30% (measured at 180 to 295 weeks), isolated right sided CDH with O\u002FE LHR \\> 45% (measured at 180 to 295 weeks), 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",{"count":114,"type":21},[24],"The purpose of this study is to evaluate successful placement and removal of Fetoscopic Endoluminal Tracheal Occlusion (FETO) device in cases of intrathoracic liver herniation with isolated left congenital diaphragmatic hernia (LCDH) with Observed\u002FExpected (O\u002FE) Lung to Head Circumference Ratio (LHR) \\\u003C 30% or isolated right congenital diaphragmatic hernia (RCDH) with O\u002FE LHR \\\u003C 45%,to compare survival to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation and isolated LCDH with O\u002FE LHR \\\u003C 30% that receive FETO procedure performed at 27 weeks 0 days to 29weeks 6 days of gestation to those with intrathoracic liver herniation, isolated LCDH and o\u002Fe LRH \\\u003C 30% that undergo expectant management, to compare the neonatal survival rate to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation, isolated RCHD with o\u002Fe LHR \\\u003C 45% that undergo FETO procedure performed at 27 weeks 0 days to 29 weeks 6 days gestation to those with intrathoracic liver herniation, isolated RCHD and o\u002Fe LHR \\\u003C 45% that elect to proceed with expectant management, to evaluate the frequency of maternal and fetal complications associated with FETO procedure, to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated LCDH survivors with o\u002Fe LHR \\\u003C30% when compared to isolated LCDH with o\u002Fe LRH \\\u003C30% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation and to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated RCDH survivors with o\u002Fe LHR ≤ 45% when compared to isolated RCHD with LHR \\\u003C 45% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation",[27],[145],"2025-08-13",{"date":560,"type":37},"2025-08-19",{"date":562,"type":37},"2025-03-04",{"date":152,"type":21},{"name":268,"class":44},{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":15,"acronym":570,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":111,"minAge":18,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":22,"phases":573,"briefSummary":574,"conditions":575,"keywords":576,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":241},"100584060","safety-and-efficacy-of-feto-in-cdh-a-phase-iii-trial-100584060","NCT06884423","Safety and Efficacy of FETO in CDH: A Phase III Trial","CHOP FETO","Inclusion Criteria:\n\n1. Pregnant women age 18 years and older\n2. Singleton pregnancy\n3. Normal fetal karyotype with confirmation by culture results, whole exome sequencing (WES), whole genome sequencing (WGS), or chromosomal microarray with non-pathologic variants. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is greater than 26 weeks.\n4. Gestational age at enrollment is prior to 29 weeks 6 days\n5. Liver is intrathoracic\n6. Isolated left congenital diaphragmatic hernia (CDH) with observed\u002Fexpected lung to head ratio (O\u002FE LHR) of less than 30% at enrollment (18\\^0 to 29\\^5 weeks), or:\n7. Isolated right CDH with O\u002FE LHR equal to or less than 45% at enrollment (18\\^0 to 29\\^5 weeks).\n8. Cervical length by transvaginal ultrasound equal to or greater than 20 mm within 24 hours of fetoscopic endoluminal tracheal occlusion (FETO) procedure\n9. Patient meets psychosocial criteria\n10. Informed consent\n\nExclusion Criteria:\n\n1. Patient is less than 18 years of age\n2. Multi-fetal pregnancy\n3. History of natural rubber latex allergy\n4. Preterm labor, cervix shortened (less than 20 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa\n5. Psychosocial ineligibility, precluding consent:\n\n   * Inability to reside within 30 minutes of the Children's Hospital of Philadelphia (CHOP) and inability to comply with the travel for the follow-up requirements of the trial\n   * 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 CHOP\n6. Bilateral CDH, isolated left sided CDH with O\u002FE LHR greater than or equal to 30% (measured at 18\\^0 to 29\\^5 weeks), isolated right sided CDH with O\u002FE LHR greater than 45% (measured at 180 to 295 weeks), as determined by ultrasound\n7. No Liver herniation into thoracic cavity.\n8. Additional fetal anomaly by ultrasound, magnetic resonance imaging (MRI), or echocardiogram at the fetal treatment center. Exclude chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (ie. CDH and congenital heart disease) or presence of an underlying genetic syndrome (ie. Fryns).\n9. Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy\n10. History of incompetent cervix with or without cerclage\n11. Placental abnormalities (previa, abruption, accrete) known at time of enrollment.\n12. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.\n13. 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.\n14. Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality\n15. There is no safe or technically feasible fetoscopic approach to balloon placement.\n16. Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy.",{"count":114,"type":21},[24],"Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs from growing and developing normally.\n\nIn severe cases, CDH can lead to serious disease and death at birth. For these babies, treatment before birth may allow the lungs to grow enough before birth so these children are capable of surviving and thriving.",[27,224],[229,230],"2025-07-22",{"date":579,"type":37},"2025-07-25",{"date":581,"type":37},"2025-04-07",{"date":583,"type":21},"2032-04",{"name":585,"class":44},"Holly L Hedrick, MD",{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":145,"officialTitle":590,"acronym":197,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":111,"minAge":18,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":22,"phases":593,"briefSummary":594,"conditions":595,"keywords":596,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":45},"100337509","fetoscopic-endoluminal-tracheal-occlusion-100337509","NCT03674372","Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Right and Left Congenital Diaphragmatic Hernia (CDH)","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 or Right CDH with liver up\n* Gestation at enrollment prior to 29 wks plus 6 days\n* SEVERE pulmonary hypoplasia with Ultra Sound L-sided O\u002FE LHR \\\u003C 25% or R-sided O\u002FE LHR \\\u003C45%\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* Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care",{"count":220,"type":21},[24],"The purpose of this research study is to see if the FETO surgery and FETO release (surgery to remove the device) works and is safe for babies with severe right or left Congenital Diaphragmatic Hernia (CDH). CDH is a condition in which a hole in the baby's diaphragm allows the abdominal organs to move into the chest and limit lung growth. The goal of the FETO device is to block the airway with a balloon-type device, allowing fluid to build up and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life.",[27],[230,197,27],"2025-06-05",{"date":599,"type":37},"2025-06-10",{"date":601,"type":37},"2018-11-16",{"date":603,"type":21},"2030-03",{"name":605,"class":44},"University of Colorado, Denver",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":111,"minAge":18,"maxAge":4,"enrollmentInfo":613,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":614,"conditions":615,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":45},"100343332","3d-animation-and-models-to-aid-management-of-fetal-cdh-100343332","NCT03750266","3D Animation and Models to Aid Management of Fetal CDH","The Role of 3D Images and Models to Aid Management of Cases of Congenital Diaphragmatic Hernia Diagnosed in the Antenatal Period. Consecutive Patients Studied From Diagnosis to Post Operative Period.","Inclusion Criteria:\n\n* Target Population: pregnancy women attending Jessop Wing Fetal medicine unit.\n* Accessible population: Pregnant women attending Jessop Wing Fetal medicine unit. Whose fetus had a CDH and are referred to MRI.\n* Study population: Pregnant women attending Jessop Wing Fetal medicine unit. Whose fetus had a CDH and are referred to MRI and agree to take part in the study.\n\nExclusion Criteria:\n\n* Not able to give informed consent due to any reason including poor understanding of English\n* Under 18 years of age.\n* Unable to complete the fetal MRI process due to either metal implants or claustrophobia.",{"count":477,"type":21},"We wish to use the images a mother would have done as part of her normal medical care and make both 3D animations and 3D models of the baby and it's CDH. This will both help the parents see what the problem is and also allow the surgeons, who will operate on the baby once it has been born, to see the size of the hole and what organs are in the wrong place.",[27],"2025-05-15",{"date":618,"type":37},"2025-05-16",{"date":620,"type":37},"2017-10-04",{"date":622,"type":21},"2025-06-30",{"name":624,"class":44},"Sheffield Teaching Hospitals NHS Foundation Trust",{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":629,"acronym":197,"eligibilityCriteria":630,"healthyVolunteers":54,"sex":111,"minAge":18,"maxAge":112,"enrollmentInfo":631,"targetDuration":4,"studyType":22,"phases":632,"briefSummary":633,"conditions":634,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":642,"locationsCount":45},"100284706","feto-endoscopic-tracheal-occlusion-feto-for-severe-congenital-diaphragmatic-hernia-100284706","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",{"count":20,"type":21},[24],"Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.",[27,224,635],"Pulmonary; Hypertension","2025-05-07",{"date":638,"type":37},"2025-05-11",{"date":640,"type":37},"2016-11",{"date":207,"type":21},{"name":523,"class":44}]