FETO for Congenital Diaphragmatic Hernia
(CHOP FETO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new approach to assist babies with congenital diaphragmatic hernia (CDH), a serious birth defect. CDH creates a hole in the diaphragm, allowing organs to press against the lungs and potentially hindering their development. The trial tests a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO), where a balloon is placed in the fetal airway to promote lung growth before birth. Pregnant women carrying a single baby with a specific type of CDH and certain lung measurements may qualify for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve outcomes for future babies with CDH.
Do I need to stop my current medications for the trial?
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 prior data suggests that the FETO procedure is safe for treating congenital diaphragmatic hernia?
Previous studies have identified FETO (Fetoscopic Endoluminal Tracheal Occlusion) as a promising option for treating severe congenital diaphragmatic hernia (CDH). Research shows that FETO has been successfully performed in about 98% of cases, typically around the 28th week of pregnancy.
Regarding safety, FETO remains experimental. It has been associated with higher survival rates in severe CDH cases, but its complete role is not yet fully understood. While generally well-tolerated, FETO is a complex procedure with inherent risks. Detailed safety information and potential side effects are still under investigation. Prospective participants should discuss the potential risks and benefits with their healthcare provider.12345Why are researchers excited about this trial?
Researchers are excited about Fetoscopic Endoluminal Tracheal Occlusion (FETO) for congenital diaphragmatic hernia (CDH) because it offers a unique approach by using a detachable balloon to encourage lung growth before birth. Unlike current treatments that typically involve surgical repair after birth, FETO focuses on prenatal intervention to potentially improve lung development and function. This method targets the condition at a critical developmental stage, which could lead to significantly better outcomes for infants with CDH compared to the traditional postnatal treatments.
What evidence suggests that FETO is effective for congenital diaphragmatic hernia?
Research has shown that FETO, or Fetoscopic Endoluminal Tracheal Occlusion, can be a promising treatment for severe congenital diaphragmatic hernia (CDH). In this trial, one group of participants will undergo the FETO procedure, which involves placing a small balloon in the baby's airway to promote lung growth before birth. In severe cases, babies who underwent FETO had better survival rates compared to those who did not. One study found that FETO was successfully performed in 98% of cases, demonstrating its practicality for many. Although results can vary, current evidence supports FETO as a viable option for improving outcomes in severe CDH cases.13567
Who Is on the Research Team?
Holly L Hedrick, MD, FACS
Principal Investigator
Children's Hospital of Philadelphia
Are You a Good Fit for This Trial?
This trial is for pregnant women over 18 with a single pregnancy and a fetus diagnosed with severe Congenital Diaphragmatic Hernia (CDH). Eligible participants must be before 29 weeks and 6 days of gestation, have no major health issues or contraindications to surgery, and be able to stay near the hospital. Those with multiple pregnancies, latex allergies, additional fetal anomalies, or other medical conditions that could affect surgery safety are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Prenatal Evaluation
Standard prenatal evaluation including medical history, physical exam, ultrasound, echocardiogram, MRI, and psychosocial assessment
FETO Intervention
Placement of a detachable balloon in the fetal airway between 27+0/7 - 29+6/7 gestational age, with removal between 34+0/7 - 34+6/7 gestational age
Postnatal Stabilization and Surgery
Postnatal stabilization and subsequent surgery to repair the diaphragm at CHOP
Follow-up
Infants are monitored for safety and effectiveness at 6, 12, 18, and 24 months of age
What Are the Treatments Tested in This Trial?
Interventions
- FETO
Trial Overview
The trial tests FETO (Fetoscopic Endoluminal Tracheal Occlusion) using GoldBAL2 Balloon and BALTACCIBDPE100 Catheter in fetuses with CDH. The procedure aims to promote lung growth by temporarily blocking the trachea in utero. It's designed for cases where the liver has moved into the chest cavity due to diaphragm herniation.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Fetoscopic Endoluminal Tracheal Occlusion (FETO) will be performed by placing a detachable balloon inside the fetal airway and removing the balloon after several weeks. Devices: GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter. Assignment will be non-randomized. 40 maternal/fetal dyads will be enrolled in this arm.
The control arm includes patients eligible for FETO according to side of defect, O/E LHR, and liver position who undergo expectant management rather than FETO intervention. Assignment will be non-randomized. 40 maternal/fetal dyads will be enrolled in this arm.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Holly L Hedrick, MD
Lead Sponsor
Citations
Feasibility, safety, and outcome of fetoscopic endoluminal ...
Our data have shown that FETO represents a viable option for severe type of CDH fetuses with reasonable outcome.
Fetal Endoscopic Tracheal Occlusion (FETO) for Left and ...
FETO was successfully performed in 47/48 (98%) cases at an average gestational age (GA) of 28.5 (24–31.6) weeks including 22 (47%) moderate LCDH ...
3.
childrenscolorado.org
childrenscolorado.org/advances-answers/recent-articles/fetoscopic-endoluminal-tracheal-occlusion/FETO for Congenital Diaphragmatic Hernia
In a sub-analysis comparing patients with severe cases, 63 underwent FETO and 43 were managed expectantly. Although survival was similar for ...
Fetal surgery for congenital diaphragmatic hernia in the ...
Current level I evidence demonstrates improved survival rates in patients with severe CDH who undergo FETO. •. Survival impact of FETO in moderate CDH before 30 ...
Fetal Surgery for Severe Left Diaphragmatic Hernia: A Cost ...
A recent randomized trial highlighted the improved maternal and neonatal outcomes associated with fetoscopic endoluminal tracheal occlusion (FETO) surgical ...
Outcomes of fetuses with severe diaphragmatic hernia after ...
Despite research showed FETO increased survival in severe left-sided CDH from 24 % to 49 % [4], the role of FETO remains unclear and is considered experimental.
Safety and Efficacy of Fetoscopic Endoluminal Tracheal ...
The purpose of this study is to evaluate the safety and efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in cases of severe Congenital Diaphragmatic ...
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