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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100)
DeviceA Goldballoon Detachable Balloon (GOLDBAL2) will be inserted in the airway of the fetus with severe congenital diaphragmatic hernia (o/e LHR \<25% with liver up) during the FETO procedure between gestational age 27 weeks 0 days and 29 weeks and 6 days. The fetal tracheal balloon will be removed at between 34 weeks 0 days and 34 weeks 6 days gestation or earlier as indicated.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: FETO with GOLDBAL2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of successful placements of Goldballoon Detachable Balloon at gestational age 27 weeks 0 days (27w0d) to 29 weeks 6 days (29w6d)
Successful completion of balloon insertion in fetuses with severe CDH defined as direct visualization of balloon above the carina at the time of FETO procedure.
Time frame
27 weeks zero days to 29 weeks 6 days2
Number of successful removals of balloon
Removal of the balloon will ideally be done at 34th week of gestation or prior to delivery.
Time frame
Removal prior to delivery, ideally at 34 weeks gestationSecondary outcomes
1
Change in fetal lung growth
Prenatal ultrasound will measure the observed-to-expected lung to head ratio (o/e LHR) at weekly visits while the balloon is in place and after balloon removal. Fetal lung growth will be calculated as the difference between the o/e LHR pre-balloon placement and the o/e LHR after balloon removal.
Time frame
Baseline (before balloon placement) to first ultrasound after balloon removal2
Gestational age at delivery
Gestational age at delivery will be recorded.
Time frame
At the time of delivery3
Infant survival
Infant survival will be measured from delivery to discharge, at 6, 12, and 24 months of age.
Time frame
Birth to 24 months4
Number of infants requiring extra corporeal membrane oxygenation (ECMO) support
Use of ECMO will be collected from medical chart review.
Time frame
Birth to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Aimen F. Shaaban, MD
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor institution
Source ClinicalTrials.gov