FETO Therapy for Congenital Diaphragmatic Hernia

(FETO Trial)

Overseen By James E Fisher, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Children's Hospitals and Clinics of Minnesota

Disqualifiers: Twin pregnancy, Right-sided CDH, Maternal HIV, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Midwest Fetal Care Center, a collaboration between Allina Health and Children's Minnesota. This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant people and their baby who meet study criteria.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that you should not be using illicit drugs or abusing over-the-counter drugs.

What data supports the effectiveness of the treatment FETO therapy for congenital diaphragmatic hernia?

Research shows that FETO therapy can improve the survival of infants with congenital diaphragmatic hernia by promoting better lung growth and development, although it may lead to some complications like tracheomegaly (enlarged windpipe) and preterm delivery. ^{1 2 3 4 5}

How is FETO therapy different from other treatments for congenital diaphragmatic hernia?

FETO therapy is unique because it involves placing a balloon in the unborn baby's trachea (windpipe) to help the lungs grow better before birth, which is different from other treatments that are usually done after birth. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for pregnant women over 18 with a severe case of left-sided congenital diaphragmatic hernia in their fetus (O/E LHR < 25%). They must be at 27-29 weeks gestation, have no other lethal fetal anomalies or major heart defects, and agree to stay within 15 minutes of the Midwest Fetal Care Center.

Inclusion Criteria

I am an adult woman pregnant with a baby diagnosed with severe left-sided CDH.

Acceptance of responsibility to stay locally (within 15 minutes) of MWFCC and Children's Minnesota - Minneapolis

My condition does not involve life-threatening anomalies, genetic variants, or abnormal chromosome numbers.

Exclusion Criteria

Short cervix (20 mm or less)

Maternal factors precluding safe fetal surgery

History of natural rubber latex allergy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

FETO Placement Procedure

Placement of the FETO device before gestational age 29 weeks 6 days

1 day

1 visit (in-person)

FETO Removal Procedure

Removal of the FETO device no later than 35 weeks 6 days gestational age

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including routine care in the NICU and monitoring up to 2 years of age

up to 2 years

Treatment Details

Interventions

• FETO therapy

Trial Overview The study tests Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy on fetuses with severe CDH. It aims to increase lung volume before birth, potentially improving survival rates post-birth. The pilot will enroll ten participants to assess feasibility.

Participant Groups

Group I: FETO therapy Experimental Treatment 1 Intervention

FETO therapy

FETO therapy is already approved in United States for the following indications:

Approved in United States as FETO for:

• Severe congenital diaphragmatic hernia (CDH)

Who Is Running the Clinical Trial?

Children's Hospitals and Clinics of Minnesota

Lead Sponsor

Trials

67

Recruited

5,022,000+

Allina Health System

Collaborator

Trials

60

Recruited

1,178,000+

Findings from Research

A systematic review of 10 studies involving 449 infants who underwent fetoscopic endoluminal tracheal occlusion (FETO) for congenital diaphragmatic hernia (CDH) found that 6% of infants born alive and 12% of those who survived to discharge experienced symptomatic tracheal complications.

These complications ranged from mild symptoms like barking cough to severe issues requiring tracheostomy, highlighting the need for ongoing monitoring of FETO survivors and the development of devices that reduce tracheal injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of symptomatic tracheal morbidities after fetoscopic endoluminal tracheal occlusion: a systematic review and meta-analysis. Tho, ALW., Rath, CP., Tan, JKG., et al.[2023]

Fetoscopic endoluminal tracheal occlusion (FETO) is a feasible and safe procedure for treating severe congenital diaphragmatic hernia (CDH), with successful balloon insertion in all 11 cases studied, and no severe maternal adverse events reported.

The procedure resulted in a 45% survival rate at 90 days of age and at discharge for the treated fetuses, indicating its potential effectiveness in promoting fetal lung growth in cases of isolated left-sided CDH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: A Japanese experience. Wada, S., Ozawa, K., Sugibayashi, R., et al.[2020]

Fetal endoscopic tracheal occlusion (FETO) is a treatment for severe congenital diaphragmatic hernia that can lead to complications such as tracheomegaly in infants, as observed in a series of five cases.

This study highlights a new potential risk associated with FETO, suggesting that the compliant fetal airway may be damaged by balloon occlusion, warranting careful evaluation of the trachea in infants who underwent this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tracheomegaly: a complication of fetal endoscopic tracheal occlusion in the treatment of congenital diaphragmatic hernia. McHugh, K., Afaq, A., Broderick, N., et al.[2021]

In a study of 16 cases of severe congenital diaphragmatic hernia (CDH) treated with fetoscopic endoluminal tracheal occlusion (FETO), the survival rate at 6 months was 50%, indicating a promising outcome for this prenatal intervention.

Survivors of the treatment had earlier balloon insertion and better changes in amniotic fluid levels and lung-to-head ratio compared to those who did not survive, suggesting that earlier intervention may improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal surgery using fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: a single-center experience. Idelson, A., Tenenbaum-Gavish, K., Danon, D., et al.[2023]

Fetoscopic endoluminal tracheal occlusion (FETO) was performed on 21 cases of severe congenital diaphragmatic hernia (CDH), resulting in a postnatal survival rate of 47% for infants with isolated unilateral CDH.

The study found that the increase in the observed/expected lung-to-head ratio (O/E LHR) after the FETO procedure was significantly greater in surviving infants compared to those who did not survive, indicating a potential predictor of survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetoscopic Endoluminal Tracheal Occlusion in Fetuses with Severe Diaphragmatic Hernia: A Three-Year Single-Center Experience. Persico, N., Fabietti, I., Ciralli, F., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Prevalence of symptomatic tracheal morbidities after fetoscopic endoluminal tracheal occlusion: a systematic review and meta-analysis. [2023]

2. Australia pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: A Japanese experience. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Tracheomegaly: a complication of fetal endoscopic tracheal occlusion in the treatment of congenital diaphragmatic hernia. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Fetal surgery using fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: a single-center experience. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Fetoscopic Endoluminal Tracheal Occlusion in Fetuses with Severe Diaphragmatic Hernia: A Three-Year Single-Center Experience. [2018]