FETO for Congenital Diaphragmatic Hernia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a treatment called Fetal Endotracheal Occlusion (FETO) for babies with congenital diaphragmatic hernia (CDH), a condition where abdominal organs move into the chest and hinder lung development. The trial aims to determine if using a tiny balloon to block the trachea while the baby is still in the womb can enhance lung growth and reduce high blood pressure in the lungs after birth. Pregnant women carrying a single baby diagnosed with severe CDH and willing to stay in Houston for the procedure and delivery may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could significantly improve outcomes for babies with CDH.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have an allergy or previous adverse reaction to a study medication, you may be excluded from participating.
What prior data suggests that the FETO procedure is safe for treating congenital diaphragmatic hernia?
Research has shown that Fetal Endotracheal Occlusion (FETO) is a safe treatment for severe congenital diaphragmatic hernia (CDH) in unborn babies. Studies have found that FETO can increase survival rates at birth. Data from the TOTAL trials, a series of studies on FETO, showed significant improvements in these outcomes.
FETO is generally well-tolerated. The procedure involves placing a small balloon in the unborn baby's airway to aid lung development, which is later removed. While any procedure carries some risk, FETO has been used for over 30 years, and current research suggests it is a reasonable option for severe CDH cases. It is important to discuss potential risks with a healthcare provider to make the best decision for the baby.12345Why are researchers excited about this trial?
Fetal Endotracheal Occlusion (FETO) is unique because it offers a prenatal intervention for congenital diaphragmatic hernia (CDH), where most treatments occur post-birth. FETO involves placing a detachable balloon in the fetus's trachea to promote lung growth, which is different from standard surgical repairs typically done after delivery. Researchers are excited about FETO because it allows for early intervention, potentially improving lung development and survival rates even before the baby is born.
What evidence suggests that FETO is effective for congenital diaphragmatic hernia?
Research has shown that a procedure called fetal endotracheal occlusion (FETO) can improve survival rates for babies with congenital diaphragmatic hernia (CDH) at birth. FETO temporarily blocks the windpipe, aiding lung growth and function. In this trial, some participants will undergo the FETO procedure, while others will join a non-FETO control group. Specifically, babies with severe CDH who underwent FETO were more likely to overcome high blood pressure in the lungs by their first birthday compared to those who did not. A review of multiple studies also found that FETO could enhance survival rates for babies with CDH. While FETO shows promise, further research is needed to understand its long-term benefits.25678
Who Is on the Research Team?
Michael Belfort, MD PhD
Principal Investigator
Baylor College of Medicine - Texas Children's Hospital
Are You a Good Fit for This Trial?
This trial is for pregnant women aged 18-45 with a single pregnancy and a fetus diagnosed with severe left or right-sided CDH. The fetus should be between 28 to almost 32 weeks old, have normal heart function or minor issues not affecting outcome, and the mother must stay in Houston post-procedure until delivery. Exclusions include latex allergy, surgery risks, fetal genetic anomalies impacting survival, maternal BMI over 40, or high risk of fetal hemophilia.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
FETO Procedure
Fetal endotracheal occlusion (FETO) procedure is performed using a fetoscopically delivered balloon device to temporarily occlude the trachea and increase lung distension.
Postoperative Monitoring
Serial measurements of sonographic lung volume and LHR, amniotic fluid level, and membrane status are monitored weekly. Comprehensive ultrasonography for fetal growth is performed every four weeks.
Balloon Retrieval
The balloon is retrieved no later than 36+6/7 weeks of gestation. The patient remains within 30 minutes of the hospital until retrieval.
Follow-up
Participants are monitored for safety and effectiveness after delivery, with regular check-ups at 6 weeks, 3 months, 6 months, 1 year, and 2 years to assess the baby's breathing and development.
What Are the Treatments Tested in This Trial?
Interventions
- Fetal Endotracheal Occlusion (FETO)
Fetal Endotracheal Occlusion (FETO) 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?
Michael A Belfort
Lead Sponsor
Baylor College of Medicine
Collaborator