Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT06739356
Status:
RECRUITING
Last Update Posted:
2025-08-19
First Post:
2024-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
North American Fetal Therapy Network for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065630', 'term': 'Hernias, Diaphragmatic, Congenital'}], 'ancestors': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006548', 'term': 'Hernia, Diaphragmatic'}, {'id': 'D000082122', 'term': 'Internal Hernia'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2031-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2024-12-09', 'studyFirstSubmitQcDate': '2024-12-16', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of neonates that survived', 'timeFrame': 'from delivery to hospital discharge (up to 12 months)'}, {'measure': 'Number of Successful placement of FETO device', 'timeFrame': '10-60 minutes after surgery begins'}, {'measure': 'Number of Successful removal of FETO device', 'timeFrame': 'immediately after the procedure (about 1 hour after start of surgery)'}, {'measure': 'FETO procedure complications', 'timeFrame': 'end of study (24 months)', 'description': 'Complications include, Failure FETO insertion procedure, FETO device dislodgement potentially requiring a second FETO insertion, Fetal intraoperative injury, Procedural hemorrhage, Bleeding from insertion site or Abruptions, Post-procedural hemorrhage PPROM, Preterm delivery, Chorioamnion separation,Chorioamnionitis, Polyhydramnios, Oligohydramnios,Emergent removal due to obstetrical complication, Failed percutaneous or fetoscopic removal requiring cesarean section or exit procedure for removal, Neonatal death due to asphyxia if delivery before FETO removal and Non-reassuring fetal heart rate monitoring'}], 'secondaryOutcomes': [{'measure': 'Number of infants that survived', 'timeFrame': '6 months'}, {'measure': 'Number of infants that survived', 'timeFrame': '12 months'}, {'measure': 'Number of infants that survived', 'timeFrame': '18 months'}, {'measure': 'Number of infants that survived', 'timeFrame': '24 months'}, {'measure': 'Number of infants that show presence of pulmonary hypertension', 'timeFrame': '6 months'}, {'measure': 'Number of infants that show presence of pulmonary hypertension', 'timeFrame': '12 months'}, {'measure': 'Number of infants that show presence of pulmonary hypertension', 'timeFrame': '18 months'}, {'measure': 'Number of infants that show presence of pulmonary hypertension', 'timeFrame': '24 months'}, {'measure': 'Number of infants that show need for supplemental oxygen', 'timeFrame': '6 months'}, {'measure': 'Number of infants that show need for supplemental oxygen', 'timeFrame': '12 months'}, {'measure': 'Number of infants that show need for supplemental oxygen', 'timeFrame': '18 months'}, {'measure': 'Number of infants that show need for supplemental oxygen', 'timeFrame': '24 months'}, {'measure': 'Number of infants that show periventricular leukomalacia', 'timeFrame': 'at less than 2 months postnatally'}, {'measure': 'Number of Infants that develop sepsis', 'timeFrame': '6 months'}, {'measure': 'Number of Infants that develop sepsis', 'timeFrame': '12 months'}, {'measure': 'Number of Infants that develop sepsis', 'timeFrame': '18 months'}, {'measure': 'Number of Infants that develop sepsis', 'timeFrame': '24 months'}, {'measure': 'Number of infants that develop Intraventricular hemorrhage (grade 0-III)', 'timeFrame': '6 months'}, {'measure': 'Number of infants that develop Intraventricular hemorrhage (grade 0-III)', 'timeFrame': '12 months'}, {'measure': 'Number of infants that develop Intraventricular hemorrhage (grade 0-III)', 'timeFrame': '18 months'}, {'measure': 'Number of infants that develop Intraventricular hemorrhage (grade 0-III)', 'timeFrame': '24 months'}, {'measure': 'Number of infants that develop retinopathy of prematurity (grade 3 or higher)', 'timeFrame': '6 months'}, {'measure': 'Number of infants that develop retinopathy of prematurity (grade 3 or higher)', 'timeFrame': '12 months'}, {'measure': 'Number of infants that develop retinopathy of prematurity (grade 3 or higher)', 'timeFrame': '18 months'}, {'measure': 'Number of infants that develop retinopathy of prematurity (grade 3 or higher)', 'timeFrame': '24 months'}, {'measure': 'Number of infants that develop gastro-esophageal reflux', 'timeFrame': '6 months'}, {'measure': 'Number of infants that develop gastro-esophageal reflux', 'timeFrame': '12 months'}, {'measure': 'Number of infants that develop gastro-esophageal reflux', 'timeFrame': '18 months'}, {'measure': 'Number of infants that develop gastro-esophageal reflux', 'timeFrame': '24 months'}, {'measure': 'Number of infant hospital readmissions', 'timeFrame': 'end of study (24 months)'}, {'measure': 'Cause of infant hospital readmissions', 'timeFrame': 'end of study (24 months)'}, {'measure': 'Number of infants that show childhood growth failure', 'timeFrame': '6 months'}, {'measure': 'Number of infants that show childhood growth failure', 'timeFrame': '12 months'}, {'measure': 'Number of infants that show childhood growth failure', 'timeFrame': '18 months'}, {'measure': 'Number of infants that show childhood growth failure', 'timeFrame': '24 months'}, {'measure': 'Number of infants that show recurrence of CDH repair', 'timeFrame': '6 months'}, {'measure': 'Number of infants that show recurrence of CDH repair', 'timeFrame': '12 months'}, {'measure': 'Number of infants that show recurrence of CDH repair', 'timeFrame': '18 months'}, {'measure': 'Number of infants that show recurrence of CDH repair', 'timeFrame': '24 months'}, {'measure': 'Number of infants that develop bowel obstruction', 'timeFrame': '6 months'}, {'measure': 'Number of infants that develop bowel obstruction', 'timeFrame': '12 months'}, {'measure': 'Number of infants that develop bowel obstruction', 'timeFrame': '18 months'}, {'measure': 'Number of infants that develop bowel obstruction', 'timeFrame': '24 months'}, {'measure': 'Number of infants that show neurodevelopmental delay as assessed by the Bayley Scales of Infant and Toddler Development-III(BSID)', 'timeFrame': '24 months', 'description': "Three domains will be measured as follows: Cognitive Scale, Language Scale (Receptive and Expressive) and Motor Scale (Fine and Gross Motor Skills). Scores are derived by converting raw scores from completed tasks into scale scores and composite scores. These scores are then utilized to assess the child's performance in relation to norms established based on typically developing children of the same age\n\nMean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning.\n\nScores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay.\n\nScore below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment.\n\nIn general, scores falling in the lowest 10th percentile indicate developmental delay"}, {'measure': 'Number of infants that develop bronchopulmonary dysplasia', 'timeFrame': '6 months'}, {'measure': 'Number of infants that develop bronchopulmonary dysplasia', 'timeFrame': '12 months'}, {'measure': 'Number of infants that develop bronchopulmonary dysplasia', 'timeFrame': '18 months'}, {'measure': 'Number of infants that develop bronchopulmonary dysplasia', 'timeFrame': '24 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Fetoscopic Endoluminal Tracheal Occlusion'], 'conditions': ['Congenital Diaphragmatic Hernia']}, 'descriptionModule': {'briefSummary': '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/Expected (O/E) Lung to Head Circumference Ratio (LHR) \\< 30% or isolated right congenital diaphragmatic hernia (RCDH) with O/E LHR \\< 45%,to compare survival to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation and isolated LCDH with O/E LHR \\< 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/e LRH \\< 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/e LHR \\< 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/e LHR \\< 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/e LHR \\<30% when compared to isolated LCDH with o/e LRH \\<30% 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/e LHR ≤ 45% when compared to isolated RCHD with LHR \\< 45% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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/e LHR \\< 30% at enrollment (180 to 295 wks.). or\n* Isolated RCDH with o/e LHR \\< 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 (\\<20 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/E LHR ≥ 30% (measured at 180 to 295 weeks), isolated right sided CDH with O/E 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"}, 'identificationModule': {'nctId': 'NCT06739356', 'briefTitle': 'North American Fetal Therapy Network for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia', 'orgStudyIdInfo': {'id': 'HSC-MS-24-0984'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fetal Treatment arm (FETO Group)', 'interventionNames': ['Device: Fetal Treatment arm (FETO Group)']}, {'type': 'NO_INTERVENTION', 'label': 'Expectant Management Arm (Control Group)'}], 'interventions': [{'name': 'Fetal Treatment arm (FETO Group)', 'type': 'DEVICE', 'description': 'Participants will undergo FETO surgery at at 27 weeks 0 days - 29 weeks 6 days gestation.Balloon insertion into the fetal trachea will be performed. This will be followed by weekly \\\\ ultrasound monitoring and MRI at 3 weeks following FETO insertion and removal of the balloon which will be performed at at 34 weeks 0 days to 34 weeks 6 days. Planned delivery will occur after 37 weeks. The follow-up phase will be conducted from birth to 24 months of age', 'armGroupLabels': ['Fetal Treatment arm (FETO Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anthony Johnson, DO', 'role': 'CONTACT', 'email': 'Anthony.Johnson@uth.tmc.edu', 'phone': '(713) 500-5859'}, {'name': 'Elisa P Garcia', 'role': 'CONTACT', 'email': 'Elisa.I.Garcia@uth.tmc.edu', 'phone': '(713) 500-7434'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Anthony Johnson, DO', 'role': 'CONTACT', 'email': 'Anthony.Johnson@uth.tmc.edu', 'phone': '(713) 500-5859'}, {'name': 'Elisa Garcia', 'role': 'CONTACT', 'email': 'Elisa.I.Garcia@uth.tmc.edu', 'phone': '(713) 500-7434'}], 'overallOfficials': [{'name': 'Anthony Johnson, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Anthony Johnson', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}