FETO Treatment for Congenital Diaphragmatic Hernia

Safety and Efficacy of FETO in CDH Phase III

Recruiting Phase 3 Interventional Study
Congenital Diaphragmatic Hernia Pulmonary Hypoplasia Pulmonary Hypertension
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 50
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
75 (estimated)
Sponsor
Children's Hospital Medical Center, Cincinnati · Other
Who this trial is looking for

This trial is looking for pregnant women with specific types of congenital diaphragmatic hernia to participate in a treatment involving tracheal occlusion. Participants will need to be able to consent and meet certain health criteria.

Are You a Good Fit for This Trial?
Rules you out Incompetent cervixMaternal HIVMaternal Hepatitis-BMaternal Hepatitis-C

You may be able to join if

  • I am a pregnant woman 18 years or older.
  • I have a singleton pregnancy.
  • I am between 180 to 295 weeks pregnant.
  • I have intrathoracic liver herniation.
  • I have isolated Left CDH with lung-to-head ratio below 30%.
  • I have isolated Right CDH with lung-to-head ratio below 45%.
  • I have a normal fetal karyotype confirmed by tests.
  • I have a cervical length over 20 mm.

You may not be able to join if

  • I am under 18 years of age.
  • I have a multi-fetal pregnancy.
  • I have a history of natural rubber latex allergy.
  • I have preterm labor or a shortened cervix.
  • I cannot travel to Cincinnati Children's Hospital Medical Center.
  • I have bilateral CDH or specific abnormal lung-to-head ratio thresholds.
  • I have additional fetal anomalies or genetic syndromes.
  • I have a severe medical condition during pregnancy.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Pregnant women 18 years and older, who are able to consent * Singleton pregnancy * Gestational age at enrollment is prior to 296 weeks * Intrathoracic liver herniation * Isolated Left CDH with o/e LHR \< 30% at enrollment (180 to 295 weeks) or * Isolated Right CDH with o/e LHR…
Contacts

Foong-Yen Lim, MD

(513) 636-6259

Foong-Yen.Lim@cchmc.org

CONTACT