FETO for Congenital Diaphragmatic Hernia
(FETO Trial)
Trial Summary
What is the purpose of this trial?
Despite advances in prenatal diagnosis and postnatal therapies, including extracorporeal membrane oxygenation (ECMO), inhaled nitric oxide therapy, and ventilator strategies that minimize ventilator-induced lung injury, morbidity and mortality rates for babies with congenital diaphragmatic hernia (CDH) remain high. The survival relates to the degree of prenatal lung compression and the subsequent impairment of pulmonary function following delivery. Prenatal assessment by ultrasound or magnetic resonance imaging allows to estimate the severity by relating the circumference of the lung contralateral to the hernia to the fetal head circumference lung to head ratio (LHR) and by noting the degree of upward herniation of the liver. Based on the observed to expected lung to head ratio (O/E LHR), prenatally diagnosed congenital diaphragmatic hernia can be prognostically assessed. While overall survival of congenital diaphragmatic hernia is approximately 60%, an O/E LHR \<25% is associated with survival between 11-24%. The rationale for fetal therapy in severe congenital diaphragmatic hernia is to restore adequate lung growth for neonatal survival. Prenatal tracheal occlusion 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 intrauterine endoscopic techniques (fetoscopy) to position and remove endoluminal tracheal balloons in utero (fetoscopic endotracheal occlusion = FETO). Recently, the Belgium group published summary results of FETO showing an improved survival in 175 patients with isolated left CDH from 24% to 49%. We hypothesize that FETO can be performed and may increase survival and decrease morbidity when compared to standard prenatal care for the treatment of severe CDH in the most severe group of fetuses with left CDH (O/E LHR \< 30%). FETO therapy will be considered in two subgroups: those with and O/E LHR \<25% (severe group) and those with an O/E between 25 to \<30% (less severe group).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the treatment for congenital diaphragmatic hernia?
Is FETO generally safe for humans?
FETO (Fetoscopic Endoluminal Tracheal Occlusion) has been shown to be feasible and safe in several fetal surgery programs, although it can lead to complications like preterm premature rupture of membranes, which may affect the timing of delivery. The procedure involves a balloon that contains a metallic component, which could pose risks during MRI scans, but these risks have been evaluated for safety.12367
How is the FETO treatment for congenital diaphragmatic hernia different from other treatments?
FETO (Fetoscopic Endoluminal Tracheal Occlusion) is unique because it involves placing a balloon in the fetus's trachea (windpipe) to promote lung growth before birth, which is different from traditional surgical repairs done after birth. This approach aims to improve survival rates by enhancing lung development in severe cases of congenital diaphragmatic hernia.12468
Research Team
Ahmet Baschat, MD
Principal Investigator
Johns Hopkins University
Eligibility Criteria
This trial is for pregnant women over 18 with a single, anatomically and chromosomally normal fetus diagnosed with severe left-sided congenital diaphragmatic hernia (CDH) and an observed to expected lung to head ratio (O/E LHR) under 30%. It's not for those with right-sided or bilateral CDH, other major anomalies, O/E LHR ≥ 30%, latex allergies, preterm labor risks like a short cervix, or maternal health issues that make surgery risky.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants undergo Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure
Delivery and Follow-up
Participants are monitored from delivery until the child reaches 24 months of age
Treatment Details
Interventions
- 11540KE and Balt Goldbal 2 balloon
11540KE and Balt Goldbal 2 balloon is already approved in European Union, United States for the following indications:
- Severe congenital diaphragmatic hernia (CDH)
- Severe congenital diaphragmatic hernia (CDH)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
KARL STORZ Endoscopy-America, Inc.
Industry Sponsor