Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT02530073

Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH

Led by Connecticut Children's Medical Center · Updated on 2025-05-15

15

Participants Needed

1

Research Sites

778 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.

CONDITIONS

Official Title

Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women age 18 years and older, who are able to consent
  • Singleton pregnancy
  • Normal fetal karyotype
  • Fetal diagnosis of isolated left congenital diaphragmatic hernia (CDH) with liver up
  • Gestational age at enrollment prior to 29 weeks plus 6 days
  • Severe pulmonary hypoplasia with ultrasound observed/expected lung-to-head ratio (O/E LHR) less than 25%
Not Eligible

You will not qualify if you...

  • Pregnant women under 18 years of age
  • Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
  • Technical limitations that prevent fetoscopic surgery
  • Allergy to rubber latex
  • Preterm labor, shortened cervix (less than 15 mm at enrollment or within 24 hours of FETO balloon insertion), or uterine anomalies that increase preterm labor risk
  • Placenta previa
  • Psychosocial factors preventing consent
  • Right-sided or bilateral diaphragmatic hernia, major associated anomalies, or isolated left-sided CDH with O/E LHR 25% or higher
  • Inability to stay at the FETO treatment site during tracheal occlusion, delivery, and postnatal care

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

Connecticut Children's Medical Center

Hartford, Connecticut, United States, 06106

Actively Recruiting

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Research Team

K

Katie E Boyle, MPH

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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Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH | DecenTrialz