Fetoscopic surgery to treat severe congenital diaphragmatic hernia in fetuses
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
This study is testing a new prenatal surgery to see if it can help unborn babies with a serious lung condition called congenital diaphragmatic hernia grow their lungs better and survive after birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT04583644 on ClinicalTrials.gov |
What this trial studies
This pilot trial investigates the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) as a prenatal therapy for fetuses diagnosed with severe left congenital diaphragmatic hernia (CDH). The procedure aims to obstruct the normal flow of lung fluid, promoting lung growth and improving neonatal survival rates. Eligible participants include pregnant women with singleton pregnancies and specific criteria related to the severity of CDH. The study is conducted at the University of California San Francisco Fetal Treatment Center.
Who should consider this trial
Good fit: Ideal candidates are pregnant women over 18 years old with a singleton pregnancy and severe left CDH.
Not a fit: Patients with conditions other than isolated left CDH or those who do not meet the specific eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve lung development and survival rates for newborns with severe congenital diaphragmatic hernia.
How similar studies have performed: While this approach is novel, other studies have explored fetal interventions for congenital conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women age 18 years and older * 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 US LHR O/E \< 25% (measured at 180 to 295 weeks) at the time of surgery * Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound * Family meets psychosocial criteria * Pre-authorization from third-party payor for fetal intervention OR the ability to self-pay for study treatment. For all patients without insurance or the means to pay for the procedure, an attempt will be made to obtain Medicaid. Insurers that have denied payment have noted that this remains an experimental procedure. As this is a feasibility study and not being offered as either standard of care or as a prospective randomized control trial to determine efficacy, the investigators do not feel that there is a breach of ethical standards. * Informed consent Exclusion Criteria: * Failure to meet all inclusion criteria * Patient \< 18 years of age * Multi-fetal pregnancy * 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 * Family does not meet psychosocial criteria. Reasons for exclusion include: insufficient social support, inability to understand requirements of the study, inability to reside in or near San Francisco. * Right sided CDH or bilateral CDH, isolated left sided with LHR O/E \< 25% (measured at 180 to 295 weeks) as determined by ultrasound * Additional fetal anomaly by ultrasound, MRI, or echocardiogram at the fetal treatment center. Exclude chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (ie. CDH and congenital heart disease) or presence of an underlying genetic syndrome (ie. Fryns). No cases will be removed post hoc if abnormalities are discovered in the course of post-operative 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 * 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
Where this trial is running
San Francisco, California
- University of California San Francisco Fetal Treatment Center — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Hanmin Lee, MD — University of California, San Francisco
- Study coordinator: Katie Archbold, BA
- Email: fetus@ucsf.edu
- Phone: 415-476-0445
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.