FETO for Congenital Diaphragmatic Hernia

(CHOP FETO Trial)

Overseen By Annaliese Aarthun

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Holly L Hedrick, MD

Disqualifiers: Multifetal pregnancy, Latex allergy, Preterm labor, others

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

Compensation: Varies

Number of Visits: 5

80 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment FETO for Congenital Diaphragmatic Hernia?

Research shows that FETO (fetoscopic endoluminal tracheal occlusion) significantly improves survival rates in babies with severe congenital diaphragmatic hernia (CDH). A meta-analysis of randomized controlled trials found that FETO increased survival rates compared to standard care, with a notable improvement in outcomes for those with severe cases. ^{1 2 3 4 5}

How does the FETO treatment for congenital diaphragmatic hernia differ from other treatments?

FETO (fetoscopic endotracheal occlusion) is a unique prenatal treatment for congenital diaphragmatic hernia (CDH) that involves blocking the fetus's windpipe to promote lung growth before birth, which is different from traditional postnatal surgical repairs. This approach aims to increase survival rates in severe cases of CDH by addressing the condition while the baby is still in the womb. ^{1 2 6 7 8}

What is the purpose of this trial?

Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs from growing and developing normally. In severe cases, CDH can lead to serious disease and death at birth. For these babies, treatment before birth may allow the lungs to grow enough before birth so these children are capable of surviving and thriving.

Research Team

Holly L Hedrick, MD, FACS

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

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

My liver is located in my chest area.

Patient meets psychosocial criteria

Singleton pregnancy

Exclusion Criteria

Multi-fetal pregnancy

History of natural rubber latex allergy

Psychosocial ineligibility precluding consent: inability to reside within 30 minutes of CHOP and comply with travel for follow-up, lack of support person available to stay with patient at CHOP

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Prenatal Evaluation

Standard prenatal evaluation including medical history, physical exam, ultrasound, echocardiogram, MRI, and psychosocial assessment

1-2 weeks

Multiple visits (in-person)

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

7-8 weeks

Weekly prenatal monitoring visits (in-person)

Postnatal Stabilization and Surgery

Postnatal stabilization and subsequent surgery to repair the diaphragm at CHOP

Immediate post-birth period

Inpatient care

Follow-up

Infants are monitored for safety and effectiveness at 6, 12, 18, and 24 months of age

24 months

4 visits (in-person)

Treatment Details

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.

Participant Groups

Group I: FETO in CDH Experimental Treatment 1 Intervention

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.

Group II: Expectant Management in CDH Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Holly L Hedrick, MD

Lead Sponsor

Trials

1

Recruited

80+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Fetal endoscopic tracheal occlusion for moderate and severe congenital diaphragmatic hernia: a systematic review and meta-analysis of randomized controlled trials. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Fetoscopic endoluminal tracheal occlusion versus expectant management for fetuses with severe left-sided congenital diaphragmatic hernia. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Outcome for Congenital Diaphragmatic Hernia at the Age of 1 Year in the Era of Fetal Intervention. [2018]

4. Pakistan pubmed.ncbi.nlm.nih.gov

Foetal endoscopic tracheal occlusion for severe congenital diaphragmatic hernia--a systemic review and meta-analysis of randomized controlled trials. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Postnatal care setting and survival after fetoscopic tracheal occlusion for severe congenital diaphragmatic hernia: A systematic review and meta-analysis. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Fetoscopic endotracheal occlusion for severe isolated diaphragmatic hernia: initial experience from a single clinic in Brazil. [2016]

7. England pubmed.ncbi.nlm.nih.gov

3D Virtual Broncoscopy before FETO Procedure in a Fetus with Severe, Isolated Left Congenital Diaphragmatic Hernia. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Fetoscopic tracheal occlusion for treatment of non-isolated congenital diaphragmatic hernia. [2022]