Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)

Phase

N/A

Condition

Hernia

Treatment

Placement of the GOLDBAL2 balloon

Clinical Study ID

NCT05354505

AAAU1357

Ages > 18
All Genders

Study Summary

This is a single site, single arm, non-randomized, pilot trial to assess the feasibility and safety of treating severe congenital diaphragmatic hernia (CDH) with Fetal Endoscopic Tracheal Occlusion (FETO) at Columbia University Irving Medical Center (CUIMC)/ NewYork-Presbyterian Hospital (NYP).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability (meetspsychosocial criteria below) for the duration of the study
Pregnant women, age 18 years and older
Singleton pregnancy
No pathogenic variants on microarray or pathologic findings on karyotype; results byfluorescence in situ hybridization (FISH) will be acceptable if patient is >26 weeks
Fetal echocardiogram with changes expected with CDH and no major structural cardiacdefects
Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as o/e LHR <25%with liver up
Gestational age at FETO procedure: if o/e LHR <25%, will be done at 27 weeks plus 0days to 29 weeks plus 6 days
Meets psychosocial criteria

Willing to reside within 30 minutes of NewYork-Presbyterian Sloane Hospital forWomen/Columbia University Irving Medical Center (CUIMC) and ability to maintainfollow up appointments. NYP/CUIMC will work with the study participant toassist in securing housing 30 minutes from the hospital if this is a challengeto her.
Patient has a support person (e.g. spouse, partner, friend, parent) that isavailable to stay with her for the duration of the pregnancy nearNewYork-Presbyterian Sloane Hospital for Women/Columbia University IrvingMedical Center (CUIMC)
Willing to comply with restrictions of daily living including inability toexercise, have intercourse, or return to work

Exclusion

Exclusion Criteria:

Multi-fetal pregnancy
History of latex allergy
History of preterm labor or incompetent cervix (requiring cerclage), short cervix (<20mm), or uterine anomaly predisposing to preterm labor
Psychosocial ineligibility

Inability to reside within 30 minutes of NewYork-Presbyterian Sloane Hospitalfor Women/Columbia University Irving Medical Center (CUIMC) or inability tomaintain follow up appointments
Social work will meet with each patient to evaluate the social situation andsupport system. Identifiable issues of social instability or compliance withthe protocol will exclude her as a potential candidate.

Bilateral CDH, unilateral CDH with o/e LHR > 25%, or unilateral CDH with o/e LHR <25% but liver completely down in abdomen
Additional fetal or genetic abnormalities that would impact care after delivery orbe known to have an impact on outcome
Maternal contraindications to elective fetoscopic surgery
Significant placental abnormalities (abruption, chorioangioma, accreta) known attime of enrollment and/or surgery
Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmunethrombocytopenia affecting the current pregnancy.Maternal HIV, Hepatitis B withpositive surface antigen, Hepatitis C with presence of virus in maternal blood dueto risk of fetal transmission during the procedure
No safe or feasible fetoscopic approach to balloon placement
Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
Participation in another intervention study that influences maternal and fetalmorbidity and mortality.

Study Design

Placement of the GOLDBAL2 balloon

January 01, 2026

June 30, 2028

Study Description

Congenital diaphragmatic hernia (CDH) affects 1 in 2,200 to 5,000 live births per year. The defect in the fetal diaphragm allows abdominal organs (intestine, stomach, liver, spleen) to migrate into the thorax, hindering normal lung development. The herniated contents place pressure on the developing lungs and this may result in varying degrees of pulmonary hypoplasia and associated pulmonary hypertension; both of which may be lethal. In an attempt to prenatally quantify the impact of the herniated organs on underlying lung development, prognostic tools have been developed. The most widely used prognostic indicator is lung-to-head ratio (LHR) as measured by prenatal ultrasound. The lung contralateral to the diaphragmatic defect is measured in a transverse plane at the level of the four chamber heart and its area is divided by the fetal head circumference (LHR). The LHR is tracked through the pregnancy but seems to be most strongly correlated with outcomes in the early third trimester.

Fetuses with severe CDH have a high risk of mortality. The current standard of care treatment offers postnatal repair, which is associated with overall survival of 71% in all cases. A majority (68%) of fetuses are prenatally diagnosed, and the survival in this cohort is even lower at 65%. The severity of the defect can be measured prenatally by the degree of pulmonary hypoplasia, and the survival drops to below 30% for those with expected lung volumes below 30% of expected. The purpose of the FETO procedure in severe CDH patients is to improve prenatal lung growth in order to potentially increase neonatal survival.

Connect with a study center

Columbia University Irving Medical Center/NewYork-Presbyterian
New York, New York 11021
United States
Site Not Available
Columbia University Irving Medical Center/NewYork-Presbyterian
New York 5128581, New York 5128638 11021
United States
Active - Recruiting

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