About this trial
Despite advances in prenatal diagnosis and postnatal therapies, including ECMO (Extracorporeal Membrane Oxygenation), inhaled nitric oxide therapy, and ventilator strategies that minimize ventilator-induced lung injury, morbidity and mortality rates for babies with severe CDH remain high. The rationale for fetal therapy in severe CDH is to promote adequate lung growth for neonatal survival. Prenatal tracheal occlusion obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. The investigator's goal with this pilot study is to study the feasibility of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with left CDH (LHR O/E \< 25%).
Eligibility criteria
Qualifiers
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
Disqualifiers
Failure to meet all inclusion criteria
Patient < 18 years of age
Multi-fetal pregnancy
Rubber latex allergy
Trial design
Treatments tested in this trial
- Fetoscopic Endoluminal Tracheal Occlusion Surgery
Treatment groups
Sponsors and collaborators
Hanmin Lee
Lead sponsor
University of California, San Francisco
Sponsor institution