Recruiting NCT03138863
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BALT GoldbBAL2 Detachable Balloon, Catheter System.
- Who it may be relevant to
- Registry conditions: Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia, Pulmonary Artery Hypertension. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Fetal Endoscopic Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) NCT3138863
Overview
The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).
Interventions
- Device BALT GoldbBAL2 Detachable Balloon
Latex balloon, with radio-opaque inclusion - Device Catheter System
100 cm tapered micro-catheter
Primary outcome measures
- Number of successfully completed FETO procedures [Time frame: Up to 34 weeks gestation]
- Operative time [Time frame: Up to 34 weeks gestation]
- Frequency of unplanned balloon removal [Time frame: Up to 34 weeks gestation]
- Number of incidences of maternal complications [Time frame: Up to 41 weeks gestation]
- Number of participants with maternal complications [Time frame: Up to 41 weeks gestation]
- Gestational Age at Delivery [Time frame: Up to 41 weeks gestation]
Secondary outcome measures (12)
- Fetal Lung Growth as measured via Fetal Lung Volume [Time frame: Up to 41 weeks gestation]
- Fetal Lung Growth as measured via LHR [Time frame: Up to 41 weeks gestation]
- Fetal survival [Time frame: Up to 24 months post partum]
- Number of newborns reported at each oxygen dependency grading [Time frame: Up to 24 months post partum]
- Number of occurrence of severe pulmonary hypertension [Time frame: Up to 24 months post partum]
- Number of infants requiring ECMO Support [Time frame: Up to 24 months post partum]
- Number of days in neonatal intensive care unit [Time frame: Up to 24 months post partum]
- Number of days of ventilator support [Time frame: Up to 24 months post partum]
- Number of days of maternal hospitalization [Time frame: Up to 24 months post partum]
- Number of infants reporting presence of complications [Time frame: Up to 24 months post partum]
- Number of infants requiring the use of patch or muscle flap [Time frame: Up to 24 months post partum]
- Number of participants at each route of delivery [Time frame: Day 1 (post partum)]
Eligibility criteria
Inclusion criteria
- Singleton pregnancy
- Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks.
- Isolated Left CDH with liver up
- Gestation age at enrollment prior to 29 wks plus 6 days severe pulmonary hypoplasia with ultrasound (US) O/E lung area to head circumference ratio (LHR) < 25% (measured at 180 to 296 weeks) at the time of surgery; O/E LHR 25% to <30% (measured at 300 to 316 weeks) at time of surgery.
- Gestational age at FETO procedure with O/E LHR <25% at 27 weeks 0 days to 29 weeks 6 days; with O/E LHR 25% to <30% at 30 weeks 0 days to 31 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
- Patient meets psychosocial criteria
Exclusion criteria
- Multi-fetal pregnancy
- History of natural rubber latex allergy
- Preterm labor, cervix shortened (<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
- Psychosocial ineligibility, precluding consent:
- Inability to reside within 30 minute drive of our hospital, and inability to comply with the travel for the follow-up requirements of the trial
- Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at our institution.
- Right sided CDH or bilateral CDH, isolated left sided with O/E LHR ≥30% (measured at 180 to 295 weeks) as determined by ultrasound
- Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. No cases will be removed post hoc if abnormalities are discovered in the course of postoperative monitoring
- Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
- History of incompetent cervix with or without cerclage
- Placental abnormalities (previa, abruption, accrete) 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
- Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University of Miami — Miami
- Mayo Clinic — Rochester
Identifiers
NCT: NCT03138863 · 20220033-1 · 16-008720