Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHanmin Lee

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

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

Hanmin Lee

Lead sponsor

University of California, San Francisco

Sponsor institution