Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congenital Diaphragmatic Hernias
- Sponsor
- Connecticut Children's Medical Center
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Percent of neonatal survivors at time of discharge
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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%).
Investigators
Timothy Crombleholme
Director of Fetal Care Center
Connecticut Children's Medical Center
Eligibility Criteria
Inclusion Criteria
- •Pregnant women age 18 years and older, who are able to consent
- •Singleton pregnancy
- •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
Outcomes
Primary Outcomes
Percent of neonatal survivors at time of discharge
Time Frame: Discharge from the hospital, an expected average of 12 weeks.
Feasibility, safety, and survival rates of the FETO procedure
Secondary Outcomes
- Prenatal increase in lung volume(2 weeks (prenatally))
- Number of days of Postnatal mechanical ventilator support(First 28 days of postnatal life)
- Changes in RNA content of tracheal and amniotic fluid(At time of balloon placement and removal)
- Characterization of extracellular vesicles (EVs) and miRNAs in tracheal and amniotic fluid(At time of balloon placement and removal)