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The purpose of the study is to determine if babies with left or right-sided CDH that undergo the FETO procedure survive more often and have fewer long-term complications than babies that have similar left or right-sided CDH that elect not to have the FETO procedure performed during pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FETO surgery Intervention Arm | Experimental | Eligible participants that choose the FETO Intervention Arm, will undergo two surgeries, one to place the balloon and a second to remove the balloon before delivery. |
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| Expectant Management Arm | No Intervention | Participants choose to undergo the expectant management, or routine care, of carrying a baby with Congenital Diaphragmatic Hernia (CDH). Participants will undergo a comprehensive fetal evaluation at Michigan Medicine's Fetal Diagnosis and Treatment Center (FDTC) to confirm the diagnosis and severity of the CDH. Eligibility will be based on the results of the clinical assessment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) | Device | This will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare neonatal survival to discharge in LCDH | 6-12 months (birth to discharge) | |
| Compare neonatal survival to discharge in RCDH | 6-12 months (birth to discharge) | |
| Number of successful placements the of FETO balloon Gestational age of 27 weeks 0 days gestation to 29 weeks 6 days gestation | 27weeks 0 days gestation to 29 weeks 6 days gestation | |
| Number of successful retrievals/puncture of the FETO balloon Gestational age of 33 weeks 0 days to 35 weeks 0 days | Removal prior to delivery at approximately 34 weeks of gestation | |
| Number of FETO procedure complications | FETO procedure complications include: Failure of the 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; Preterm premature rupture of membranes; Preterm delivery; Chorioamnion separation; Chorioamnionitis; Polyhydramnios; Oligohydramnios; Emergent removal due to obstetrical complication; Failed percutaneous or fetoscopic removal requiring cesarean section or Ex-Utero Intrapartum Therapy(EXIT) procedure for removal; Neonatal death due to asphyxia if delivery before FETO removal; Non-reassuring fetal heart rate monitoring. | Balloon placement to delivery (27 weeks up to delivery approximately 40 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal lung growth difference on MRI via o/e Total Fetal Lung Volume (TFLV) (FETO Intervention Arm) | Fetal MRI done prior to balloon placement and again done at approximately 2 weeks of balloon retrieval. Fetal lung growth (difference between 1st and 2nd MRIs will be calculated for FETO intervention arm only). | Baseline (prior to balloon placement) and approximately 2 weeks after balloon retrieval |
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FETO Intervention Arm: Inclusion Criteria:
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
Pregnant women, age 18 years and older
Singleton pregnancy
Normal fetal karyotype, Chromosomal Microarray (CMA) with non-pathologic variants, Whole Exome Sequencing (WES) or Whole Genome Sequencing (WGS). Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is >26 weeks.
Gestational age at enrollment prior to 29w6d
Fetal CDH with intrathoracic liver herniation with either:
Cervical length by transvaginal ultrasound >20 mm within 24hours of FETO procedure
Meets psychosocial criteria
Expectant Management Arm: Inclusion Criteria:
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
Pregnant women, age 18 years and older
Singleton pregnancy
Normal fetal karyotype, CMA with non-pathologic variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is >26 weeks. (non-intervention arm can have karyotype or microarray prenatally or postnatally)
Gestational age at enrollment prior to 29w6d
Fetal CDH with intrathoracic liver herniation with either:
Isolated left CDH with o/e LHR <30% at enrollment (18w0d-29w5d)
Isolated right CDH with o/e LHR <45% at enrollment (18w0d-29w5d)
Meets psychosocial criteria
FETO Intervention Arm: Exclusion Criteria:
Patient <18 years of age
Multi-fetal pregnancy
History of natural rubber latex allergy
Preterm labor, short cervix (<20mm within 24 hours of FETO balloon insertion procedure), or uterine anomaly strongly predisposing to preterm labor, placenta previa
History of incompetent cervix with or without cerclage
Psychosocial ineligibility
Bilateral CDH, isolated Left Congenital Diaphragmatic Hernia (LCDH) with o/e LHR > 30% (measured at 180 to 295 weeks), isolated Right Congenital Diaphragmatic Hernia (RCDH) with o/e LHR >45% (measured at 180 to 295 weeks) as determined by ultrasound
No liver herniation into the thoracic cavity.
Additional fetal anomaly or genetic/chromosomal abnormalities recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e. Fryns) by ultrasound, MRI or echocardiogram at the fetal treatment center.
Maternal contraindications to elective fetoscopic surgery or severe maternal medical condition in pregnancy
Placental abnormalities (previa, abruption, accreta) known at time of enrollment and/or surgery
Maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy
Maternal Human Immunodeficiency Virus (HIV), Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
No safe or technically feasible fetoscopic approach to balloon placement
Uterine anomalies such as large fibroids or Mullerian duct abnormality
Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
Expectant Management Arm: Exclusion Criteria:
Patient <18 years of age
Multi-fetal pregnancy
Preterm labor, short cervix (<20mm), or uterine anomaly strongly predisposing to preterm labor, placenta previa
History of incompetent cervix with or without cerclage
Psychosocial ineligibility
Bilateral CDH, isolated LCDH with o/e LHR > 30% (measured at 180 to 295 weeks), isolated RCDH with o/e LHR >45% (measured at 180 to 295 weeks), or any isolated CDH without intrathoracic liver herniation as determined by ultrasound
Additional fetal anomaly or genetic/chromosomal abnormalities recognized to alter survival prognosis (i.e. congenital heart disease) or presence of an underlying genetic syndrome (i.e. Fryns) by ultrasound, Magnetic Resonance Imaging (MRI) or echocardiogram at the fetal treatment center Placental abnormalities (per protocol)
Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irene Carter | Contact | 734-615-3883 | irenestc@med.umich.edu | |
| Erin Perrone, MD | Contact | 734-936-8464 | eperrone@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Erin Perrone, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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Participants will choose between 2 courses of care. One group is the FETO surgery Intervention Arm and the other group is the Expectant Management Arm. It is expected that there will be 20 participants in each group.
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| Fetal lung growth difference based on prenatal ultrasound via o/e LHR (Both Arms) | Prenatal ultrasound (US) will measure the o/e LHR at weekly visits while the balloon is in place (FETO intervention arm) or at routine visits per standard of care (SOC) (expectant arm). Fetal lung growth will be calculated as the difference between the o/e LHR pre- balloon placement (or 29 + 1 week in control) and the o/e LHR immediately prior to balloon removal/puncture (or 34 + 1 week in control). | Baseline (prior to balloon placement) and immediately prior to balloon removal and SOC arm 29 + 1 week and 34 +1 week |
| Long-term outcome measure infant survival rate | After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age |
| Presence of pulmonary hypertension | Determination of the ratio of the tricuspid regurgitation jet (estimation of the right ventricular systolic pressure) to systemic blood pressure where the is an objective measurement used to estimate the pulmonary artery pressure. Will be recorded as absent/none, systemic or suprasystemic. | After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age |
| Presence of need for supplemental oxygen | After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age |
| Periventricular leukomalacia at <2 months postnatally | After birth at 2 months |
| Infant sepsis | After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age |
| Intraventricular hemorrhage (grade 0-III) | After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age |
| Retinopathy of prematurity (grade 3 or higher) | After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age |
| Gastroesophageal reflux | After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age |
| Number and cause of infant hospital readmissions | After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age |
| Long-term outcome measure childhood growth failure | Childhood growth failure: weight gain velocity or decline >2 in weight, for length Z score. | After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age |
| Recurrence of CDH repair | After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age |
| Bowel obstruction | After birth at 6, 12, 18, and 24 months (+ 2 months) of corrected age |
| Neurodevelopmental delay | Bayley Scales of Infant and Toddler Development- III(BSID)>2 Standard deviation (SD) below mean, or other categorization at 24 months | 24 months (+ 2 months) of corrected age |
| Bronchopulmonary dysplasia | After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age |
| ID | Term |
|---|---|
| D065630 | Hernias, Diaphragmatic, Congenital |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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