Fetal Surgery for Congenital Diaphragmatic Hernia
(FETO Trial)
Trial Summary
What is the purpose of this trial?
The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.
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 doctor.
What data supports the effectiveness of the treatment Fetoscopic Endoluminal Tracheal Occlusion (FETO) for congenital diaphragmatic hernia?
Is FETO generally safe for humans?
Fetoscopic Endoluminal Tracheal Occlusion (FETO) is a treatment that can help babies with severe congenital diaphragmatic hernia, but it may lead to complications like tracheomegaly (enlarged windpipe) and tracheomalacia (softening of the windpipe). There are also concerns about preterm delivery (early birth) as a result of the procedure.12456
How is the FETO treatment different from other treatments for congenital diaphragmatic hernia?
FETO is a unique treatment for congenital diaphragmatic hernia because it involves a minimally invasive procedure where a balloon is placed in the fetus's trachea (windpipe) to help the lungs develop better before birth. This approach is different from traditional treatments that usually occur after birth and focus on surgical repair of the diaphragm.24578
Research Team
Timothy Crombleholme, MD
Principal Investigator
Connecticut Children's Medical Center
Eligibility Criteria
This trial is for pregnant women aged 18 or older with a single pregnancy and a fetus diagnosed with severe left-sided Congenital Diaphragmatic Hernia (CDH) where the liver has moved up into the chest. The baby must have significant lung underdevelopment, confirmed by ultrasound before 29 weeks + 6 days of gestation, and a normal karyotype.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure is performed to promote lung growth in fetuses with severe left congenital diaphragmatic hernia
Follow-up
Participants are monitored for safety and effectiveness after treatment, including postnatal mechanical ventilator support
Treatment Details
Interventions
- Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Fetoscopic Endoluminal Tracheal Occlusion (FETO) is already approved in United States, European Union 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?
Connecticut Children's Medical Center
Lead Sponsor
Medical City Children's Hospital
Lead Sponsor