Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-01-26 @ 5:12 AM
Study NCT ID:
NCT02875860
Status:
COMPLETED
Last Update Posted:
2022-06-23
First Post:
2016-08-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
'TOTAL' (Tracheal Occlusion To Accelerate Lung Growth) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D006548', 'term': 'Hernia, Diaphragmatic'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D065630', 'term': 'Hernias, Diaphragmatic, Congenital'}], 'ancestors': [{'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000082122', 'term': 'Internal Hernia'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'belfort@bcm.edu', 'phone': '832-826-7375', 'title': 'Dr. Michael Belfort', 'organization': 'Baylor College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the time period starting with enrollment of the first participant through 2 years post delivery of the baby.', 'description': 'The deaths reported in All-Cause Mortality reflect neonates who died during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Neonate Survival at Discharge From Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'OG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At hospital discharge, an average of 1.5 months', 'description': 'The null hypothesis to be tested is that there is no difference in survival between fetuses managed expectantly during pregnancy versus those undergoing antenatal therapy (FETO).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population (all participants assigned to Expectant management or FETO).'}, {'type': 'PRIMARY', 'title': 'Participants Requiring Supplemental Oxygen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'OG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 6 months of age', 'description': 'The number of survivors requiring supplemental oxygen at 6 months of age', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population (all participants assigned to Expectant management or FETO) of all subjects who survived to discharge from the hospital (primarly outcome #1).'}, {'type': 'SECONDARY', 'title': 'Grade of Oxygen Dependency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'OG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}], 'classes': [{'categories': [{'title': '0 = No Bronchopulmonary Dysplasia (BPD)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'I = FiO2 21% or room air', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'II = FiO2 22-29%', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'III = FiO2 >29%, CPAP or mechanical ventilation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 6 months of age', 'description': 'Measured as FiO2 (oxygen) amount required as a grade (0-III) with Grade 0 indicating the best outcome and Grade III indicating the worst outcome.\n\nGrade 0 = No Bronchopulmonary Dysplasia (BPD); Grade I = FiO2 21% or room air; Grade II = FiO2 22-29%; Grade III = FiO2 \\>29%, CPAP or mechanical ventilation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "As-treated ('per protocol') analysis. 1 patient in the expectant management arm died and is excluded from this analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis."}, {'type': 'SECONDARY', 'title': 'Occurrence of Severe Pulmonary Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'OG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the first 4 weeks of life (neonatal period).', 'description': 'Occurrence of severe pulmonary hypertension in the neonatal period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis."}, {'type': 'SECONDARY', 'title': 'ECMO (Extracorporeal Membrane Oxygenation) Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'OG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Neonatal period (during the first 4 weeks of life)', 'description': 'Need for extracorporeal membrane oxygenation (ECMO) in the neonatal period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis."}, {'type': 'SECONDARY', 'title': 'CDH Defect Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'OG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}], 'classes': [{'categories': [{'title': 'A: Entirely surrounded by muscle', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'B: Small (<50%) portion of the chest wall devoid of diaphragm tissue', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'C: Large (>50%) portion of the chest wall devoid of diaphragm tissue', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'D: Complete or near complete absence of the diaphragm', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured in neonate at delivery by MRI and/or ultrasound', 'description': 'Postnatal grade classification (A-D) using CDH study group standardized system with A being the smallest defects and D being the largest defects.\n\nA = Defect entirely surrounded by muscle; B = Small (\\<50%) portion of the chest wall devoid of diaphragm tissue; C = Large (\\>50%) portion of the chest wall devoid of diaphragm tissue; D = Complete or near complete absence of the diaphragm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis."}, {'type': 'SECONDARY', 'title': 'Number of Days in the NICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'OG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001', 'lowerLimit': '49', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the time of discharge from the NICU, an average of 1.5 months', 'description': 'Length of stay in the neonatal intensive care unit measured in days', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "As-treated ('per protocol') analysis. 1 patient in the expectant management arm died and is excluded from this analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis."}, {'type': 'SECONDARY', 'title': 'Ventilatory Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'OG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the first 4 weeks of life (neonatal period)', 'description': 'Length of time participants required ventilator support measured in days.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "As-treated ('per protocol') analysis. 1 patient in the expectant management arm died and is excluded from this analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis."}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Periventricular Leukomalacia (PVL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'OG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During first 2 months of life', 'description': 'As measured by presence in medical record ≤ 2 months postnatally by ultrasound (yes/no)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis."}, {'type': 'SECONDARY', 'title': 'Neonatal Sepsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'OG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the first 4 weeks of life (neonatal period)', 'description': 'As measured by presence in medical record', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis."}, {'type': 'SECONDARY', 'title': 'Intraventricular Hemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'OG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During first month of life', 'description': 'Measured as presence in neonate during first month by MRI and/or ultrasound.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis."}, {'type': 'SECONDARY', 'title': 'Retinopathy of Prematurity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'OG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the time of discharge from the NICU, an average of 1.5 months', 'description': 'Postnatal grade classification presence of grade III or higher using standardized system (yes/no)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "As-treated ('per protocol') analysis. 1 patient in the expectant management arm died and is excluded from this analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis."}, {'type': 'SECONDARY', 'title': 'Days to Full Enteral Feeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'OG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '29.5', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At hospital discharge, an average of 1.5 months', 'description': 'The number of days until full enteral feeding', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "As-treated ('per protocol') analysis. 1 patient in the expectant management arm died and is excluded from this analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis."}, {'type': 'SECONDARY', 'title': 'Gastroesophageal Reflux', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'OG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the time of discharge from the NICU, an average of 1.5 months', 'description': 'Presence of reflux above 1/3 of esophagus on clinically indicated radiologic exam', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "As-treated ('per protocol') analysis. 1 patient in the expectant management arm died and is excluded from this analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis."}, {'type': 'SECONDARY', 'title': 'CDH (Congenital Diaphragmatic Hernia) Surgery Repair', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'OG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time of birth until discharge from the NICU', 'description': 'How many days from birth until the surgery is performed to repair the defect.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis."}, {'type': 'SECONDARY', 'title': 'Use of Patch in CDH Repair', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'OG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the time of the surgical repair postnatally, up to 3 days postnatal', 'description': 'The number of participants who had a patch used in the repair of the CDH defect.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "As-treated ('per protocol') analysis. 1 patient from the FETO arm withdrew prior to receiving the FETO procedure and is excluded from this analysis."}, {'type': 'SECONDARY', 'title': 'Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'OG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 24 months of age', 'description': 'The number of participants that survived to 24 months of age', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population (all participants assigned to Expectant management or FETO).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'FG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standardized Postnatal Care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'BG001', 'title': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nGoldBal2 detachable balloon: Placement of the balloon using the plug/unplug method.\n\nBaltaccidbpe100 Delivery Catheter: The catheter assists with implanting the balloon in the plug/unplug method.\n\nStandardized postnatal care: After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.5', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '32.3', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '32.4', 'spread': '5.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '21.5', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '27.6', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '25.2', 'spread': '3.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Observed to Expected Lung to Head Ratio at Enrollment', 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '40'}, {'value': '31', 'groupId': 'BG001', 'lowerLimit': '29', 'upperLimit': '35'}, {'value': '31', 'groupId': 'BG002', 'lowerLimit': '29', 'upperLimit': '40'}]}]}], 'paramType': 'MEDIAN', 'description': 'The observed to expected lung to head ratio (O/E LHR) is calculated by taking the ratio of the lung area divided by the head circumference, compared to a reference value for the gestational age at the time of measurement.', 'unitOfMeasure': 'percentage', 'dispersionType': 'FULL_RANGE'}, {'title': 'Gestational Age at Delivery', 'classes': [{'categories': [{'measurements': [{'value': '39.2', 'groupId': 'BG000', 'lowerLimit': '39.0', 'upperLimit': '39.4'}, {'value': '39.0', 'groupId': 'BG001', 'lowerLimit': '38.0', 'upperLimit': '40.1'}, {'value': '39.0', 'groupId': 'BG002', 'lowerLimit': '38.0', 'upperLimit': '40.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'FULL_RANGE'}, {'title': 'Liver Herniation present at Enrollment', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-24', 'size': 731639, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-28T14:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'dispFirstSubmitDate': '2020-08-01', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-31', 'studyFirstSubmitDate': '2016-08-05', 'dispFirstSubmitQcDate': '2020-08-05', 'resultsFirstSubmitDate': '2022-04-28', 'studyFirstSubmitQcDate': '2016-08-18', 'dispFirstPostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-31', 'studyFirstPostDateStruct': {'date': '2016-08-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Neonate Survival at Discharge From Hospital', 'timeFrame': 'At hospital discharge, an average of 1.5 months', 'description': 'The null hypothesis to be tested is that there is no difference in survival between fetuses managed expectantly during pregnancy versus those undergoing antenatal therapy (FETO).'}, {'measure': 'Participants Requiring Supplemental Oxygen', 'timeFrame': 'At 6 months of age', 'description': 'The number of survivors requiring supplemental oxygen at 6 months of age'}], 'secondaryOutcomes': [{'measure': 'Grade of Oxygen Dependency', 'timeFrame': 'at 6 months of age', 'description': 'Measured as FiO2 (oxygen) amount required as a grade (0-III) with Grade 0 indicating the best outcome and Grade III indicating the worst outcome.\n\nGrade 0 = No Bronchopulmonary Dysplasia (BPD); Grade I = FiO2 21% or room air; Grade II = FiO2 22-29%; Grade III = FiO2 \\>29%, CPAP or mechanical ventilation.'}, {'measure': 'Occurrence of Severe Pulmonary Hypertension', 'timeFrame': 'During the first 4 weeks of life (neonatal period).', 'description': 'Occurrence of severe pulmonary hypertension in the neonatal period.'}, {'measure': 'ECMO (Extracorporeal Membrane Oxygenation) Support', 'timeFrame': 'Neonatal period (during the first 4 weeks of life)', 'description': 'Need for extracorporeal membrane oxygenation (ECMO) in the neonatal period'}, {'measure': 'CDH Defect Size', 'timeFrame': 'Measured in neonate at delivery by MRI and/or ultrasound', 'description': 'Postnatal grade classification (A-D) using CDH study group standardized system with A being the smallest defects and D being the largest defects.\n\nA = Defect entirely surrounded by muscle; B = Small (\\<50%) portion of the chest wall devoid of diaphragm tissue; C = Large (\\>50%) portion of the chest wall devoid of diaphragm tissue; D = Complete or near complete absence of the diaphragm.'}, {'measure': 'Number of Days in the NICU', 'timeFrame': 'At the time of discharge from the NICU, an average of 1.5 months', 'description': 'Length of stay in the neonatal intensive care unit measured in days'}, {'measure': 'Ventilatory Support', 'timeFrame': 'During the first 4 weeks of life (neonatal period)', 'description': 'Length of time participants required ventilator support measured in days.'}, {'measure': 'Number of Subjects With Periventricular Leukomalacia (PVL)', 'timeFrame': 'During first 2 months of life', 'description': 'As measured by presence in medical record ≤ 2 months postnatally by ultrasound (yes/no)'}, {'measure': 'Neonatal Sepsis', 'timeFrame': 'During the first 4 weeks of life (neonatal period)', 'description': 'As measured by presence in medical record'}, {'measure': 'Intraventricular Hemorrhage', 'timeFrame': 'During first month of life', 'description': 'Measured as presence in neonate during first month by MRI and/or ultrasound.'}, {'measure': 'Retinopathy of Prematurity', 'timeFrame': 'At the time of discharge from the NICU, an average of 1.5 months', 'description': 'Postnatal grade classification presence of grade III or higher using standardized system (yes/no)'}, {'measure': 'Days to Full Enteral Feeding', 'timeFrame': 'At hospital discharge, an average of 1.5 months', 'description': 'The number of days until full enteral feeding'}, {'measure': 'Gastroesophageal Reflux', 'timeFrame': 'At the time of discharge from the NICU, an average of 1.5 months', 'description': 'Presence of reflux above 1/3 of esophagus on clinically indicated radiologic exam'}, {'measure': 'CDH (Congenital Diaphragmatic Hernia) Surgery Repair', 'timeFrame': 'From the time of birth until discharge from the NICU', 'description': 'How many days from birth until the surgery is performed to repair the defect.'}, {'measure': 'Use of Patch in CDH Repair', 'timeFrame': 'At the time of the surgical repair postnatally, up to 3 days postnatal', 'description': 'The number of participants who had a patch used in the repair of the CDH defect.'}, {'measure': 'Survival', 'timeFrame': 'At 24 months of age', 'description': 'The number of participants that survived to 24 months of age'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['CDH', 'Congenital Diaphragmatic Hernia', 'Fetal Tracheal Occlusion', 'FETO', 'plug-unplug', 'GoldBal2', 'Balloon', 'Goldvalve Balloon', 'TOTAL'], 'conditions': ['Hernia', 'Hernia, Diaphragmatic', 'Hernia, DIaphragmatic, Congenital', 'Pathological Conditions, Anatomical', 'Congenital Abnormalities', 'Congenital Diaphragmatic Hernia', 'Fetal Anomaly', 'Fetal Surgery', 'Pulmonary Hypoplasia']}, 'referencesModule': {'references': [{'pmid': '17587219', 'type': 'BACKGROUND', 'citation': 'Jani J, Nicolaides KH, Keller RL, Benachi A, Peralta CF, Favre R, Moreno O, Tibboel D, Lipitz S, Eggink A, Vaast P, Allegaert K, Harrison M, Deprest J; Antenatal-CDH-Registry Group. Observed to expected lung area to head circumference ratio in the prediction of survival in fetuses with isolated diaphragmatic hernia. Ultrasound Obstet Gynecol. 2007 Jul;30(1):67-71. doi: 10.1002/uog.4052.'}, {'pmid': '18844275', 'type': 'BACKGROUND', 'citation': 'Jani JC, Benachi A, Nicolaides KH, Allegaert K, Gratacos E, Mazkereth R, Matis J, Tibboel D, Van Heijst A, Storme L, Rousseau V, Greenough A, Deprest JA; Antenatal-CDH-Registry group. Prenatal prediction of neonatal morbidity in survivors with congenital diaphragmatic hernia: a multicenter study. Ultrasound Obstet Gynecol. 2009 Jan;33(1):64-9. doi: 10.1002/uog.6141.'}, {'pmid': '15287047', 'type': 'BACKGROUND', 'citation': 'Deprest J, Gratacos E, Nicolaides KH; FETO Task Group. Fetoscopic tracheal occlusion (FETO) for severe congenital diaphragmatic hernia: evolution of a technique and preliminary results. Ultrasound Obstet Gynecol. 2004 Aug;24(2):121-6. doi: 10.1002/uog.1711.'}, {'type': 'BACKGROUND', 'citation': 'Jani J, Nicolaides K, Gratacos E, et al. 558: Short term neonatal morbidity in severe left-sided congenital diaphragmatic hernia treated by tracheal occlusion before 30 weeks. Am J Obstet Gynecol Dec;197(6),Supplement:S162.'}, {'pmid': '16769018', 'type': 'BACKGROUND', 'citation': 'Jani JC, Nicolaides KH, Gratacos E, Vandecruys H, Deprest JA; FETO Task Group. Fetal lung-to-head ratio in the prediction of survival in severe left-sided diaphragmatic hernia treated by fetal endoscopic tracheal occlusion (FETO). Am J Obstet Gynecol. 2006 Dec;195(6):1646-50. doi: 10.1016/j.ajog.2006.04.004. Epub 2006 Jun 12.'}, {'pmid': '19658113', 'type': 'BACKGROUND', 'citation': 'Jani JC, Nicolaides KH, Gratacos E, Valencia CM, Done E, Martinez JM, Gucciardo L, Cruz R, Deprest JA. Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. Ultrasound Obstet Gynecol. 2009 Sep;34(3):304-10. doi: 10.1002/uog.6450.'}, {'pmid': '19508989', 'type': 'BACKGROUND', 'citation': 'Cannie MM, Jani JC, De Keyzer F, Allegaert K, Dymarkowski S, Deprest J. Evidence and patterns in lung response after fetal tracheal occlusion: clinical controlled study. Radiology. 2009 Aug;252(2):526-33. doi: 10.1148/radiol.2522081955. Epub 2009 Jun 9.'}, {'pmid': '20980772', 'type': 'BACKGROUND', 'citation': 'Reiss I, Schaible T, van den Hout L, Capolupo I, Allegaert K, van Heijst A, Gorett Silva M, Greenough A, Tibboel D; CDH EURO Consortium. Standardized postnatal management of infants with congenital diaphragmatic hernia in Europe: the CDH EURO Consortium consensus. Neonatology. 2010;98(4):354-64. doi: 10.1159/000320622. Epub 2010 Oct 27.'}, {'pmid': '26692079', 'type': 'BACKGROUND', 'citation': 'Snoek KG, Capolupo I, van Rosmalen J, Hout Lde J, Vijfhuize S, Greenough A, Wijnen RM, Tibboel D, Reiss IK; CDH EURO Consortium. Conventional Mechanical Ventilation Versus High-frequency Oscillatory Ventilation for Congenital Diaphragmatic Hernia: A Randomized Clinical Trial (The VICI-trial). Ann Surg. 2016 May;263(5):867-74. doi: 10.1097/SLA.0000000000001533.'}, {'pmid': '18845492', 'type': 'BACKGROUND', 'citation': 'Deprest JA, Flemmer AW, Gratacos E, Nicolaides K. Antenatal prediction of lung volume and in-utero treatment by fetal endoscopic tracheal occlusion in severe isolated congenital diaphragmatic hernia. Semin Fetal Neonatal Med. 2009 Feb;14(1):8-13. doi: 10.1016/j.siny.2008.08.010. Epub 2008 Oct 8.'}, {'pmid': '16769020', 'type': 'BACKGROUND', 'citation': 'Ruano R, Aubry MC, Barthe B, Mitanchez D, Dumez Y, Benachi A. Quantitative analysis of fetal pulmonary vasculature by 3-dimensional power Doppler ultrasonography in isolated congenital diaphragmatic hernia. Am J Obstet Gynecol. 2006 Dec;195(6):1720-8. doi: 10.1016/j.ajog.2006.05.010. Epub 2006 Jun 12.'}, {'pmid': '16774297', 'type': 'BACKGROUND', 'citation': 'Ostrea EM, Villanueva-Uy ET, Natarajan G, Uy HG. Persistent pulmonary hypertension of the newborn: pathogenesis, etiology, and management. Paediatr Drugs. 2006;8(3):179-88. doi: 10.2165/00148581-200608030-00004.'}, {'pmid': '17766505', 'type': 'BACKGROUND', 'citation': 'Congenital Diaphragmatic Hernia Study Group; Lally KP, Lally PA, Lasky RE, Tibboel D, Jaksic T, Wilson JM, Frenckner B, Van Meurs KP, Bohn DJ, Davis CF, Hirschl RB. Defect size determines survival in infants with congenital diaphragmatic hernia. Pediatrics. 2007 Sep;120(3):e651-7. doi: 10.1542/peds.2006-3040.'}, {'pmid': '17177265', 'type': 'BACKGROUND', 'citation': 'Gallot D, Boda C, Ughetto S, Perthus I, Robert-Gnansia E, Francannet C, Laurichesse-Delmas H, Jani J, Coste K, Deprest J, Labbe A, Sapin V, Lemery D. Prenatal detection and outcome of congenital diaphragmatic hernia: a French registry-based study. Ultrasound Obstet Gynecol. 2007 Mar;29(3):276-83. doi: 10.1002/uog.3863.'}, {'pmid': '10986445', 'type': 'BACKGROUND', 'citation': 'Deprest JA, Evrard VA, Verbeken EK, Perales AJ, Delaere PR, Lerut TE, Flageole H. Tracheal side effects of endoscopic balloon tracheal occlusion in the fetal lamb model. Eur J Obstet Gynecol Reprod Biol. 2000 Sep;92(1):119-26. doi: 10.1016/s0301-2115(00)00435-8.'}, {'pmid': '11083424', 'type': 'BACKGROUND', 'citation': 'Chiba T, Albanese CT, Farmer DL, Dowd CF, Filly RA, Machin GA, Harrison M. Balloon tracheal occlusion for congenital diaphragmatic hernia: experimental studies. J Pediatr Surg. 2000 Nov;35(11):1566-70. doi: 10.1053/jpsu.2000.18311.'}], 'seeAlsoLinks': [{'url': 'http://www.TOTALtrial.eu', 'label': 'Information for the public and healthcare providers.'}, {'url': 'http://www.euroCDH.org', 'label': 'Information for the public and healthcare providers.'}]}, 'descriptionModule': {'briefSummary': 'This trial will test whether temporary fetoscopic endoluminal tracheal occlusion (FETO) rather than expectant management during pregnancy, followed by standardized postnatal management, increases survival at discharge and decreases oxygen need at 6 months in case of survival till discharge.', 'detailedDescription': 'This is a multi-center, non-blinded randomized controlled trial in fetuses with isolated moderate CDH, i.e. moderate lung hypoplasia (as determined by prenatal assessment of lung development). It essentially compares fetal therapy added to conventional postnatal care, versus expectant prenatal management during pregnancy followed by conventional postnatal care.\n\nEnrollment:\n\nFollowing completion of an inclusion/exclusion criteria checklist and obtaining informed consent, the subject will be randomized into two groups ("FETO" and "expectant").\n\nProcedures:\n\nGroup I: Standardized postnatal care (expectant group): mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.\n\nGroup II: Prenatal intervention (FETO group): patients will undergo fetoscopic tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in I. In this study FETO is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.\n\nThis study trial is a pragmatical or efficacy trial: ideally mothers will deliver after removal of the balloon at those tertiary centers, typically offering postnatal care for the patient involved. In group II (FETO-group), mothers will, in between placement and removal of the balloon, thus carrying a fetus with obstructed airways, ideally remain under the care of our local fetal treatment center (further referred to as FETO center). As many as possible precautions are taken to avoid problems with balloon removal in case of earlier than expected delivery.\n\n* Balloons are to be electively removed prior to 35 weeks. FETO centers will provide 24/24 hours and 7/7 days services for management of fetuses with obstructed airways, either in utero or during labor and delivery.\n* Patients in the study and randomized to FETO, will be encouraged to stay near the FETO center. After reversal of the occlusion the patient will be referred to the tertiary care center where delivery and postnatal care will be undertaken. If the patient is not remaining at or close to the FETO center, the postnatal treatment center should organize likewise EXIT services.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 18 years or more, who are able to consent,\n2. Singleton pregnancy,\n3. Chromosomally normal fetus,\n4. Gestation at randomization prior to 31 weeks plus 5 days or so that occlusion is done at the latest on 31 weeks plus 6 days,\n5. Fetus is estimated to have moderate pulmonary hypoplasia, defined prenatally as:\n\n • O/E LHR 25-34.9% (included; irrespective of the position of the liver) • O/E LHR 35-44.9% (included) with intrathoracic liver herniation as determined by ultrasound or MRI.\n\n The O/E LHR will be determined by the FETO centers as follows:\n * Measurement of the contralateral lung area preferentially by the tracing method at the 4-chamber view of the heart; if by other method adjusted normative ranges must be used.\n * Measurement of the head circumference at the standard biparietal view of the head\n * The observed lung area: calculation of the LHR as the ratio of the measurements of the lung area to head circumference\n * The expected lung area is the lung area of a normal gestational age match, as determined by the head circumference of the index case in a normogram established for the same measurement method (tracing method in this case). A calculator for this will be available on the website of the study.\n * Calculation of the observed over expected lung area,\n6. Acceptance of randomization and the consequences for the further management during pregnancy and thereafter, this includes the required observation following FETO surgery, which lasts up to 4 weeks after balloon is in place,\n7. The patients must undertake the responsibility for either remaining close to, or at the FETO center, or being able to travel swiftly and within acceptable time interval to the FETO center until the balloon is removed. Intended postnatal treatment center must subscribe to suggested guidelines for "standardized postnatal treatment," and\n8. Provide written consent to participate.\n9. Fetus with no major anomalies that would impact the clinical course or outcomes.\n\nExclusion Criteria:\n\n1. Maternal contraindication to fetoscopic surgery or severe medical condition in pregnancy that make fetal intervention risky,\n2. Technical limitations precluding fetoscopic surgery, such as severe maternal obesity, uterine fibroids or potentially others, not anticipated at the time of writing this protocol,\n3. Preterm labor, cervix shortened (\\<15 mm at randomization) or uterine anomaly strongly predisposing to preterm labor, placenta previa,\n4. Patient age less than 18 years,\n5. Psychosocial ineligibility, precluding consent,\n6. Diaphragmatic hernia: right-sided or bilateral, major anomalies, isolated left-sided outside the O/E LHR limits for the inclusion criteria, and\n7. Patient refusing randomization, to comply with required 4-week observation after balloon placement, or to comply with return to FETO center during the time period the airways are occluded or for elective removal of the balloon.\n8. Patient allergic to latex.'}, 'identificationModule': {'nctId': 'NCT02875860', 'acronym': 'TOTAL', 'briefTitle': "'TOTAL' (Tracheal Occlusion To Accelerate Lung Growth) Trial", 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'TOTAL TRIAL: Randomized Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) Versus Expectant Management During Pregnancy in Fetuses With Left-Sided and Isolated Congenital Diaphragmatic Hernia and Moderate Pulmonary Hypoplasia', 'orgStudyIdInfo': {'id': 'H-39398'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standardized postnatal care (Expectant)', 'description': 'Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.', 'interventionNames': ['Other: Standardized postnatal care']}, {'type': 'EXPERIMENTAL', 'label': 'Prenatal Intervention (FETO)', 'description': 'Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.', 'interventionNames': ['Device: GoldBal2 detachable balloon', 'Device: Baltaccidbpe100 Delivery Catheter', 'Other: Standardized postnatal care']}], 'interventions': [{'name': 'GoldBal2 detachable balloon', 'type': 'DEVICE', 'description': 'Placement of the balloon using the plug/unplug method.', 'armGroupLabels': ['Prenatal Intervention (FETO)']}, {'name': 'Baltaccidbpe100 Delivery Catheter', 'type': 'DEVICE', 'description': 'The catheter assists with implanting the balloon in the plug/unplug method.', 'armGroupLabels': ['Prenatal Intervention (FETO)']}, {'name': 'Standardized postnatal care', 'type': 'OTHER', 'description': 'After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622', 'armGroupLabels': ['Prenatal Intervention (FETO)', 'Standardized postnatal care (Expectant)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Baylor College of Medicine/Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Michael Belfort, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Baylor College of Medicine - Texas Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michael A Belfort', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael A Belfort', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}