Trial of FETO for Severe Congenital Diaphragmatic Hernia
ConditionCongenital Diaphragmatic Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAimen F. Shaaban, MD
About this trial
This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's). This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant women who meet study criteria.
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent form
Pregnant individuals age 18 years and older
Singleton pregnancy
No pathogenic variants on prenatal chromosomal microarray or pathologic findings on karyotype analysis. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
Disqualifiers
Rubber latex allergy
Presence of chromosomal abnormalities or anatomic anomalies that are known to significantly alter survival prognosis (i.e., CDH and congenital heart disease). No cases will be removed post hoc if abnormalities are discovered during post-operative monitoring
History of preterm labor, cervix shortened to ≤20 mm at enrollment or at 24 hours prior to FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor or placenta previa
Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
Trial design
Treatments tested in this trial
- FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100)
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Aimen F. Shaaban, MD
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor institution
Source ClinicalTrials.gov