FETO Therapy for Congenital Diaphragmatic Hernia

(FETO Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Hospitals and Clinics of Minnesota

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

No Placebo Group

Approved in 1 Jurisdiction

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}

Research Team

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

Trial 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 (Device)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Midwest Fetal Care Center Minneapolis, MN

Who Is Running the Clinical Trial?

Children's Hospitals and Clinics of Minnesota

Lead Sponsor

Trials

67

Patients Recruited

5,022,000+

Allina Health System

Collaborator

Trials

60

Patients Recruited

1,178,000+

Findings from Research

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]

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]

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]

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]

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]