Fetoscopic Endoluminal Tracheal Occlusion for Congenital Diaphragmatic Hernia

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Latex allergy, Preterm labor, Placenta previa, Bilateral CDH, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) to treat babies with congenital diaphragmatic hernia (CDH). CDH occurs when a hole in the diaphragm allows organs to move into the chest, affecting lung development. The trial compares the FETO procedure to standard care to determine if it improves survival rates and reduces complications. Pregnant women with a single baby who has specific types of CDH and meet certain health criteria may be eligible.

As an unphased trial, this study provides a unique opportunity for participants to contribute to groundbreaking research that could improve outcomes for future patients.

Do I need to stop my current medications for this 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 Fetoscopic Endoluminal Tracheal Occlusion (FETO) device is safe for treating congenital diaphragmatic hernia?

Research has shown that Fetoscopic Endoluminal Tracheal Occlusion (FETO) can be safely performed in severe cases of Congenital Diaphragmatic Hernia (CDH). CDH occurs when a hole in the diaphragm allows organs to move into the chest, affecting lung development. Studies indicate that while FETO does not always improve survival rates compared to standard treatments, it is generally well-tolerated in severe cases. Specifically, one study found that 54% of patients survived to hospital discharge after FETO, with varying survival rates for different types of CDH. Another report suggests that FETO offers a reasonable balance between safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Fetoscopic Endoluminal Tracheal Occlusion (FETO) because it offers a novel approach to treating congenital diaphragmatic hernia (CDH) before birth. Unlike the standard care, which typically involves postnatal surgical repair, FETO is performed in utero and involves placing a balloon in the fetus's trachea to promote lung growth. This method aims to improve lung function and survival rates by addressing the issue during fetal development rather than waiting until after delivery. By potentially enhancing lung capacity before birth, FETO could significantly improve outcomes for newborns with CDH.

What evidence suggests that the Fetoscopic Endoluminal Tracheal Occlusion (FETO) device is effective for congenital diaphragmatic hernia?

Research shows that Fetoscopic Endoluminal Tracheal Occlusion (FETO), which participants in this trial may receive, is a promising treatment for severe congenital diaphragmatic hernia (CDH). Studies indicate that babies with severe CDH who undergo FETO have better survival rates compared to those who do not. In one study, FETO was successfully performed in 98% of cases, demonstrating its reliability. Another study highlights that FETO can lead to good outcomes for severe CDH, showing it can make a significant difference. Overall, FETO is considered a viable option for improving the survival chances of babies with severe CDH. ^{1 2 4 5 6}

Who Is on the Research Team?

Ahmet Baschat, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for pregnant individuals whose fetuses have severe left (LCDH) or right congenital diaphragmatic hernia (RCDH) with specific lung-to-head ratio measurements indicating a high risk of poor outcomes. The FETO procedure will be offered between 27 to nearly 30 weeks of gestation.

Inclusion Criteria

Pregnant women who are able to consent

Singleton pregnancy

Gestational age at enrollment is prior to 296 wks

Exclusion Criteria

History of natural rubber latex allergy

There is no safe or technically feasible fetoscopic approach to balloon placement

Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

FETO Procedure

Placement and removal of the Fetoscopic Endoluminal Tracheal Occlusion (FETO) device in cases of intrathoracic liver herniation with isolated congenital diaphragmatic hernia

27 to 29 weeks of gestation

Neonatal Intensive Care

Monitoring and care in the neonatal intensive care unit (NICU) until discharge

From delivery to hospital discharge

Follow-up

Participants are monitored for long-term outcomes, including neurodevelopmental assessments

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Trial Overview The study tests the effectiveness of the Fetoscopic Endoluminal Tracheal Occlusion (FETO) device in improving survival rates and reducing long-term health issues for babies with severe diaphragmatic hernias, compared to standard expectant management without intervention.

How Is the Trial Designed?

Group I: Fetal Treatment Arm (FETO Group) Experimental Treatment 1 Intervention

Group II: Expectant Management Arm (Control Group) Active Control 1 Intervention

Standard of care treatment for babies with congenital diaphragmatic hernia.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

KARL STORZ Endoscopy-America, Inc.

Industry Sponsor

Trials

13

Recruited

21,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11627046/

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.

2. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1521693425000720

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 ...

4. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1002/pd.6803

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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06946576

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 ...

6. chop.edu chop.edu/news/childrens-hospital-philadelphia-researchers-find-specialized-procedure-boosts-survival-infants

Children's Hospital of Philadelphia In severe cases, CDH can lead to serious disease and even death. CHOP offers FETO, a fetal surgery procedure, in select cases of the most severe ...