Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05450653

Trial of FETO for Severe Congenital Diaphragmatic Hernia

Led by Aimen F. Shaaban, MD · Updated on 2026-01-28

10

Participants Needed

1

Research Sites

475 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's). This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant women who meet study criteria.

CONDITIONS

Official Title

Trial of FETO for Severe Congenital Diaphragmatic Hernia

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form
  • Pregnant individuals age 18 years and older
  • Singleton pregnancy
  • No harmful genetic variants on prenatal chromosomal microarray or abnormal karyotype results; FISH results acceptable if > 26 weeks
  • Isolated left CDH with severe lung underdevelopment (o/e LHR ≤25% with liver up) or isolated right CDH with severe lung underdevelopment (o/e LHR ≤35% with liver up), measured between 18 weeks 0 days and 29 weeks 5 days gestation
  • Gestational age between 27 weeks 0 days and 29 weeks 6 days at the time of FETO procedure
  • Fetal echocardiogram showing expected changes from CDH without major heart defects
  • Willingness to follow all study procedures, lifestyle restrictions, and attend follow-up visits
  • Willingness to stay within 30 minutes of the Chicago Institute for Fetal Health from balloon placement to removal and ability to maintain follow-up
  • Having a support person available to stay nearby during pregnancy
  • Meeting psychosocial criteria
Not Eligible

You will not qualify if you...

  • Allergy to rubber latex
  • Presence of chromosomal abnormalities or other anatomical anomalies significantly reducing survival chances
  • History of preterm labor, cervix shortened to ≤20 mm at enrollment or 24 hours before balloon insertion, uterine anomalies increasing preterm labor risk, or placenta previa
  • Maternal medical conditions or contraindications to fetoscopic surgery
  • History of incompetent cervix with or without cerclage
  • Known placental abnormalities such as previa, abruption, accreta, or chorioangioma
  • Maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting this pregnancy
  • Positive maternal HIV, Hepatitis-B, or Hepatitis-C status; if unknown, must test negative before enrollment
  • Uterine anomalies like large or multiple fibroids or mullerian duct abnormalities
  • No safe or feasible fetoscopic approach for balloon placement
  • Participation in another intervention study affecting maternal or fetal health
  • Any other condition that may compromise safety, feasibility, or study compliance as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

A

Aimen Shaaban, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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