Infant Survival and Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of the study is to determine the infant survival and long-term effects of performing Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery and removal of the BALT Goldbal2 balloon at Children's Mercy Hospital. We hypothesize that FETO balloon placement may increase survival and decrease morbidity when compared to standard prenatal care for the treatment of severe left or right congenital diaphragmatic hernia (CDH).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study

• Pregnant persons age 18 years and older

• Singleton pregnancy

• Absence of life-limiting genetic anomalies on microarray or karyotype on amniocentesis. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks gestation

• Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects (small ventricular septal defect (VSD)/atrial septal defect (ASD) may be included as they will not alter outcome and are not life-limiting)

• Left or Right CDH with liver up without presence of concomitant life-limiting anomalies.

• Gestational age for Left-CDH at enrollment prior to 29 weeks plus 6 days for O/E LHR \<30%; for Right-CDH with O/E LHR \<45% gestational age at enrollment prior to 29 weeks plus 6 days.

• Meets psychosocial criteria

• Willing to reside within 30 minutes of Children's Mercy Hospital Fetal Health Center and ability to maintain follow up appointments

• Patient has a support person (e.g. spouse, partner, friend, or parent) that is available to stay with her for the duration of the pregnancy.

• Willing to comply with restrictions of daily living including inability to exercise, have intercourse or return to work.

Locations
United States
Missouri
Children's Mercy Hospital
RECRUITING
Kansas City
Contact Information
Primary
Inna Lobeck, M.D.
inlobeck@cmh.edu
(816) 394-7606
Time Frame
Start Date: 2024-04-14
Estimated Completion Date: 2032-01-01
Participants
Target number of participants: 20
Treatments
Experimental: Balloon Arm
Participants who consent to the insertion and the removal of the Balt GOLDBAL2 Balloon.
No_intervention: No Treatment
Patients who have been diagnosed with severe CDH at our site but choose not to participate in the study.
Sponsors
Leads: Children's Mercy Hospital Kansas City
Collaborators: University of Wisconsin, Madison, NAFTNet FETO Consortium

This content was sourced from clinicaltrials.gov