Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Pregnant women age 18 years and older, who are able to consent
• Singleton pregnancy
⁃ Fetal
• Normal Karyotype
• Fetal Diagnosis of Isolated Left CDH with liver up
• Gestation at enrollment prior to 29 wks plus 6 days
• SEVERE pulmonary hypoplasia with Ultra Sound O/E LHR \< 25%
Locations
United States
Connecticut
Connecticut Children's Medical Center
RECRUITING
Hartford
Contact Information
Primary
Katie E Boyle, MPH
Kboyle01@connecticutchildrens.org
860-837-6547
Time Frame
Start Date: 2015-09
Estimated Completion Date: 2030-08
Participants
Target number of participants: 15
Treatments
Experimental: Fetoscopic Endoluminal Tracheal Occlusion (FETO)
An un-blinded non-randomized single arm pilot study of FETO in fetuses with congenital diaphragmatic hernia (CDH)
Related Therapeutic Areas
Sponsors
Leads: Connecticut Children's Medical Center