North American Fetal Therapy Network for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

March 4, 2025

Primary Completion Date

December 1, 2029

Study Completion Date

December 1, 2031

Conditions
Congenital Diaphragmatic Hernia
Interventions
DEVICE

Fetal Treatment arm (FETO Group)

Participants will undergo FETO surgery at at 27 weeks 0 days - 29 weeks 6 days gestation.Balloon insertion into the fetal trachea will be performed. This will be followed by weekly \\ ultrasound monitoring and MRI at 3 weeks following FETO insertion and removal of the balloon which will be performed at at 34 weeks 0 days to 34 weeks 6 days. Planned delivery will occur after 37 weeks. The follow-up phase will be conducted from birth to 24 months of age

Trial Locations (1)

77030

RECRUITING

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
lead

The University of Texas Health Science Center, Houston

OTHER