FETO for Congenital Diaphragmatic Hernia

(CDH FETO Trial)

Overseen By Foong-Yen Lim, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Multi-fetal pregnancy, Latex allergy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: prenatal period up to 40 weeks gestation

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a procedure called FETO (Fetal Endoscopic Tracheal Occlusion) for babies diagnosed with congenital diaphragmatic hernia (CDH). CDH is a serious condition where a hole in the diaphragm allows organs to move into the chest, affecting lung development. The trial aims to determine if using a small balloon to temporarily block the trachea (windpipe) can enhance lung growth compared to standard care. Pregnant women with a single baby, whose fetus has severe or moderate CDH and meets certain specific conditions, might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the FETO (Fetal Endoscopic Tracheal Occlusion) procedure is generally safe for treating congenital diaphragmatic hernia (CDH) in unborn babies. Studies have found FETO to be an effective option with positive outcomes. For instance, one study reported that 54% of babies who underwent FETO survived until hospital discharge. Another study demonstrated a significant improvement in survival rates, with 40% of fetuses treated with FETO surviving, compared to only 15% without the procedure.

FETO involves placing and then removing a small balloon in the unborn baby's windpipe, aiding lung development before birth. Experienced medical teams consider the procedure safe and feasible. However, like any medical procedure, it carries risks. Overall, FETO is associated with improved survival chances for babies with severe CDH. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about FETO (fetal endoscopic tracheal occlusion) for congenital diaphragmatic hernia (CDH) because it offers a novel approach to managing this condition before birth. Unlike traditional treatments, which focus on addressing the symptoms after the baby is born, FETO involves placing a balloon in the fetus's trachea to promote lung growth while still in the womb. This method could potentially improve lung function and outcomes for babies with CDH by addressing the root of the problem earlier. By fostering lung development during pregnancy, FETO has the potential to significantly change the prognosis for affected infants.

What evidence suggests that FETO might be an effective treatment for congenital diaphragmatic hernia?

This trial will compare two approaches for fetuses with severe or moderate congenital diaphragmatic hernia. One group will receive standard care without intervention, while the other group will be offered FETO (Fetal Endoscopic Tracheal Occlusion). Studies have shown that FETO can help treat severe congenital diaphragmatic hernia (CDH) in unborn babies. Research indicates that this treatment improves survival rates in severe CDH cases. In one study, researchers successfully performed FETO in 98% of cases, suggesting the procedure is generally feasible. Another study found that using FETO reduced newborn deaths and decreased the need for critical interventions like ECMO, a life-support machine. Overall, evidence supports FETO as a promising option for improving outcomes in babies with severe CDH. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for pregnant women over 18 with a single pregnancy, carrying fetuses diagnosed with congenital diaphragmatic hernia (CDH). Eligible participants must have specific measurements of liver herniation and lung-to-head ratio, normal fetal genetic tests, and be able to stay near the medical center. Women with multiple pregnancies, other fetal anomalies or conditions that risk preterm labor are excluded.

Inclusion Criteria

Gestational age at enrollment is prior to 296 weeks

Cervical length by transvaginal ultrasound > 20 mm within 24 hours prior to FETO procedure

Patient meets psychosocial criteria

Exclusion Criteria

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

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Fetuses with severe or moderate congenital diaphragmatic hernia will receive either standard of care or FETO balloon placement/removal

prenatal period up to 40 weeks gestation

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• FETO

Trial Overview The trial is testing FETO (Fetal Endoluminal Tracheal Occlusion) against standard care in fetuses with CDH. FETO involves placing a balloon in the fetus's trachea to promote lung growth. The study aims to see if this improves outcomes compared to usual treatments.

How Is the Trial Designed?

Group I: Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlu Experimental Treatment 1 Intervention

FETO balloon placement/removal

Group II: Fetuses with severe or moderate congenital diaphragmatic hernia will receive standard of care and op Active Control 1 Intervention

no intervention standard of care

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Citations

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

Feasibility, safety, and outcome of fetoscopic endoluminal ... In conclusion, our data have shown that FETO represents a viable option for severe type of CDH fetuses with reasonable outcome. FETO performance ...

2. 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 ...

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. 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 ...

5. ajog.org ajog.org/article/S0002-9378(21)02285-7/fulltext

Fetal Surgery for Severe Left Diaphragmatic Hernia: A Cost ... In our theoretical cohort of 1,000 patients, the FETO surgery strategy resulted in a decrease in 242 neonatal deaths and 239 cases of ECMO. There were an ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07187206

NCT07187206 | Safety and Efficacy of FETO in CDH Phase III The purpose of this study is to demonstrate that the FETO procedure increases the neonatal survival to discharge and reduces long-term morbidity ...

7. mayoclinic.org mayoclinic.org/medical-professionals/obstetrics-gynecology/news/multisite-study-finds-feto-associated-with-reduced-postbirth-ecmo-for-fetuses-with-cdh/mac-20575537

Multisite study finds FETO associated with reduced ... This study observed 40% survival for fetuses treated with FETO versus 15% for fetuses expectantly managed.

8. hopkinsmedicine.org hopkinsmedicine.org/-/media/gynecology-obstetrics/documents/fetal_therapy/outcome-after-feto-treatment-of-cdh.pdf

Outcome after fetoscopic tracheal occlusion treatment of ... FETO performed in multidisciplinary single center setting is feasible and safe. Despite the severity of CDH we report significantly higher survival than.