protocolSection identificationModule nctId: NCT06281717, orgStudyIdInfo id: IRB-P00045047, briefTitle: A Pilot Study on the Role of Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2030-08-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Alireza Shamshirsaz, class: OTHER, descriptionModule briefSummary: The goal of this pilot trial is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with severe congenital diaphragmatic hernia (CDH). The research team will investigate the feasibility and safety of the FETO procedure, as well as determine whether FETO can improve lung growth before birth, and survival after birth.This study will enroll 10 pregnant participants to undergo the FETO procedure at a gestational age of 27 weeks 0 days to 29 weeks 6 days. The participant will be monitored for a few weeks, and then the FETO removal procedure will be performed ideally at 34 weeks 0 days to 34 weeks 6 days, but may be indicated earlier as determined by the Maternal Fetal care team. The pregnant participant and their baby will continue to be monitored during delivery and up until the child reaches 2 years of age., conditionsModule conditions: Congenital Diaphragmatic Hernia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Fetal Endotracheal Occlusion (FETO), outcomesModule primaryOutcomes measure: Successful Ballon Placement, primaryOutcomes measure: Successful Balloon Removal, primaryOutcomes measure: Balloon placement operative time, primaryOutcomes measure: Balloon removal operative time, primaryOutcomes measure: Type of FETO release, primaryOutcomes measure: Maternal Complications, primaryOutcomes measure: Gestational age at delivery, secondaryOutcomes measure: Fetal lung volume, secondaryOutcomes measure: O/E LHR, secondaryOutcomes measure: Infant survival, secondaryOutcomes measure: Oxygen dependency, secondaryOutcomes measure: Number of infants requiring ECMO, secondaryOutcomes measure: NICU stay, secondaryOutcomes measure: Ventilator support, secondaryOutcomes measure: Presence of periventricular leukomalacia, secondaryOutcomes measure: Presence of neonatal sepsis, secondaryOutcomes measure: Presence of intraventricular hemorrhage, secondaryOutcomes measure: Retinopathy of prematurity, secondaryOutcomes measure: Presence of gastro-esophageal reflux, secondaryOutcomes measure: CDH repair type, secondaryOutcomes measure: Pulmonary function, secondaryOutcomes measure: Infant Neurodevelopment, secondaryOutcomes measure: Route of delivery, secondaryOutcomes measure: Maternal hospitalization, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Boston Children's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Brittany Gudanowski, role: CONTACT, phone: 617-919-6658, email: Brittany.Gudanowski@childrens.harvard.edu, contacts name: Maternal Fetal Care Center, role: CONTACT, phone: 617-355-6512, email: MFCCFetalResearchStudies-dl@childrens.harvard.edu, contacts name: Alireza Shamshirsaz, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Eyal Krispin, MD, role: SUB_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False