Clinical trial NCT02530073: Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
Official title: Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Diaphragmatic Hernias
Keywords: congenital diaphragmatic hernia
FETO
tracheal occlusion
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.

Detailed description: Prenatal tracheal occlusion (TO) obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. European colleagues have developed foregut endoscopy and techniques to position and remove endoluminal tracheal balloons in utero. Recently, the Belgium group published summary results of FETO showing an improved survival in 175 patients with isolated left CDH from 24% to 49%.

The goal of this pilot study is to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH Observed/expected lung-to-head ratio \< 25%(O/E LHR \< 25%).

Eligibility criteria: Inclusion Criteria:

* Pregnant women age 18 years and older, who are able to consent
* Singleton pregnancy

Fetal

* Normal Karyotype
* Fetal Diagnosis of Isolated Left CDH with liver up
* Gestation at enrollment prior to 29 wks plus 6 days
* SEVERE pulmonary hypoplasia with Ultra Sound O/E LHR \< 25%

Exclusion Criteria:

* Pregnant women \<18 years of age.
* Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
* Technical limitations precluding fetoscopic surgery
* Rubber latex allergy
* Preterm labor, cervix shortened (\<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
* Psychosocial ineligibility, precluding consent
* Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 25%
* Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care

Primary outcomes:
measure: Percent of neonatal survivors at time of discharge
timeFrame: Discharge from the hospital, an expected average of 12 weeks.
Secondary outcomes:
measure: Prenatal increase in lung volume
timeFrame: 2 weeks (prenatally)
measure: Number of days of Postnatal mechanical ventilator support
timeFrame: First 28 days of postnatal life
measure: Changes in RNA content of tracheal and amniotic fluid
timeFrame: At time of balloon placement and removal
measure: Characterization of extracellular vesicles (EVs) and miRNAs in tracheal and amniotic fluid
timeFrame: At time of balloon placement and removal
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
Study officials:
affiliation: Connecticut Children's Medical Center
name: Timothy Crombleholme, MD
role: PRINCIPAL_INVESTIGATOR
References: