Fetoscopic tracheal balloon occlusion for severe left congenital diaphragmatic hernia
Fetal Endoscopic Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) NCT3138863
This research will try placing a temporary balloon in the fetal windpipe to help lungs grow in pregnancies where the baby has a severe left congenital diaphragmatic hernia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Miami Academic / other |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT03138863 on ClinicalTrials.gov |
What this trial studies
FETO uses a fetoscope and catheter to place a detachable balloon in the fetal trachea, temporarily blocking airway outflow so lung fluid accumulates and the lungs can expand. Candidates are selected based on isolated left CDH with liver herniation and low observed/expected lung-to-head ratio within specific gestational age windows, and require a normal fetal karyotype and psychosocial clearance. The balloon is removed before birth or allowed to deflate per protocol, with close monitoring for preterm labor, membrane rupture, and other procedure-related complications. Patients receive coordinated prenatal care at specialized fetal surgery centers and postnatal neonatal management after delivery.
Who should consider this trial
Good fit: Ideal candidates are pregnant people with a singleton pregnancy carrying a fetus with isolated left CDH with liver up, a normal karyotype, and an O/E LHR below the protocol thresholds measured within the specified gestational age windows who can attend care at the enrolling center.
Not a fit: Patients unlikely to benefit include those with multi-fetal pregnancies, major chromosomal or structural anomalies, right-sided or mild CDH (higher O/E LHR), or those who cannot undergo or delay delivery at a center experienced in fetal surgery.
Why it matters
Potential benefit: If successful, FETO could increase fetal lung growth, improving survival and reducing the severity of pulmonary hypoplasia and pulmonary hypertension.
How similar studies have performed: Previous cohort series and randomized/semi-randomized studies of FETO have shown increased lung size and improved survival for selected severe left CDH cases but also a higher rate of preterm birth and maternal/fetal complications.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Miami, Florida and 1 other locations
- University of Miami — Miami, Florida, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Terminated)
Study contacts
- Principal investigator: Rodrigo Ruano, M.D., Ph.D. — University of Miami
- Study coordinator: Rodrigo A Ruano, MD, Ph.D
- Email: rodrigo.ruano@miami.edu
- Phone: 305.689.8001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.