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The purpose of this research is to determine if babies who undergo a Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure survive more often and have less long-term complications than babies who have similarly severe Congenital Diaphragmatic Hernia (CDH) that have not had the FETO procedure performed during pregnancy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FETO Surgery |
| ||
| Standard of Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fetoscopic Endoluminal Tracheal Occlusion | Device | Mothers who chose to undergo a Fetoscopic Endoluminal Tracheal Occlusion procedure for severe left and right congenital diaphragmatic hernia will be followed until the infant is 2 years of age. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of FETO procedure complications | FETO procedure complications are defined as device dislodgement, intraoperative injury to fetus, procedural hemorrhage, post-procedural hemorrhage, preterm delivery, chorioamnion separation, chorioamnionitis, polyhydramnios, oligohydramnios, failed percutaneous or fetoscopic removal requiring cesarean section or EXIT procedure for removal, neonatal death due to asphyxia (if delivery before FETO removal), non-reassuring fetal heart rate monitoring. | 2 years |
| Neonatal survival to discharge | Number of neonates to survive from delivery to hospital discharge | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of pulmonary hypertension | Number infants to be diagnosed with pulmonary hypertension. Pulmonary hypertension is a determination of the ratio of the tricuspid regurgitation jet (estimation of the right ventricular systolic pressure) to systemic blood. Will be record as absent/none, systemic or suprasystemic | 6, 12, 18, and 24 months of age |
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Inclusion Criteria:
Exclusion Criteria:
Multi-fetal pregnancy
History of natural rubber latex allergy
Preterm labor, cervix shortened (<20 mm at enrollment or within 24 to 48 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
Psychosocial ineligibility, precluding consent:
Bilateral CDH, isolated left sided CDH with O/E LHR 30% (measured at 180 to 295 weeks), isolated right sided CDH with O/E LHR > 45% (measured at 180 to 295 weeks), as determined by ultrasound.
No intrathoracic liver herniation
Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns) by ultrasound, MRI, or echocardiogram at the fetal treatment center.
Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
History of incompetent cervix with or without cerclage
Placental abnormalities (previa, abruption, accreta) known at time of enrollment
Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
Uterine anomaly such as large or multiple fibroids or Mullerian duct abnormality
There is no safe or technically feasible fetoscopic approach to balloon placement
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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Pregnant patients with fetuses affected by congenital diaphragmatic hernia meeting the inclusion criteria above-mentioned and not meeting exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| OB/GYN Clinical Research Team, Krista Storing | Contact | 507-266-3382 | ||
| OB/GYN Clinical Research Team, Krista Storing | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Mauro Schenone, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Standard of Care | Other | Mothers who chose to receive expectant management for severe left and right congenital diaphragmatic hernia will be followed until the infant is 2 years of age. |
|
| Need for supplemental oxygen | Number of infants to require supplemental oxygen | 6, 12, 18, and 24 months of age |
| Periventricular leukomalacia at < 2 months postnatally | Number of infants to be diagnosed with periventricular leukomalacia at < 2 months postnatally | 2 months |
| Intraventricular hemorrhage (grade 0-III) | Number of infants to be diagnosed with intraventricular hemorrhage (grade 0-III) | 6, 12, 18, and 24 months of age |
| Retinopathy of prematurity (grade 3 or higher) | Number infants to be diagnosed with retinopathy of prematurity (grade 3 or higher) | 6, 12, 18, and 24 months of age |
| Gastro-esophageal reflux | Number of infants to be diagnosed with gastro-esophageal reflux | 6, 12, 18, and 24 months of age |
| Number of infant hospital readmissions | Number of infants readmitted to hospital after initial discharge | 6, 12, 18, and 24 months of age |
| Childhood growth failure | Number of infants to experience childhood growth failure: weight gain velocity or decline >2 in weight, for length Z score. | 6, 12, 18, and 24 months of age |
| Recurrence of Congenital Diaphragmatic Hernia (CDH) repair | Number of infants to require additional congenital diaphragmatic hernia (CDH) repair procedures. | 6, 12, 18, and 24 months of age |
| Bowel obstruction | Number of infants to experience a bowel obstruction. | 6, 12, 18, and 24 months of age |
| Neurodevelopmental delay | Number of infants to experience neurodevelopmental delay: Bayley Scales of Infant and Toddler Development-III(BSID)>2 SD below mean, or other categorization at 24 months. | 6, 12, 18, and 24 months of age |
| Bronchopulmonary dysplasia | Number of infants to be diagnosed with bronchopulmonary dysplasia (BPD). It is defined according to the mode of respiratory support administered at 36 weeks' postmenstrual age, regardless of the prior duration or current level of oxygen therapy. The optimal diagnostic criteria will be no BPD, no support; grade 1 BPD, nasal cannula S2 L/min; grade 2 BPD, nasal cannula >2 L/min or noninvasive positive airway pressure; and grade 3 BPD, invasive mechanical ventilation. | 6, 12, 18, and 24 months of 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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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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