Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH

This study is looking at a treatment called Fetoscopic Endoluminal Tracheal Occlusion (FETO) for babies with a severe condition called Congenital Diaphragmatic Hernia (CDH). CDH means there's a hole in the baby's diaphragm, which can stop their lungs from growing properly. FETO involves placing a small balloon in the baby's windpipe while still in the womb to help the lungs grow. Researchers want to see if this treatment can be successfully used in babies with very severe left-sided CDH, specifically those with a lung-to-head ratio (O/E LHR) less than 25%. The main goal is to see how many babies survive and are discharged from the hospital, which is expected to be around 12 weeks after birth. This study is for pregnant women aged 18 or older with a single baby diagnosed with isolated left CDH, liver in the chest, and severe lung underdevelopment, before 29 weeks and 6 days of pregnancy. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 15 participants. It is designed to test the feasibility of implementing FETO therapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed until the baby is discharged from the hospital, which is expected to be an average of 12 weeks.

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NCT02530073

Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH

Recruiting
NAAges 18+InterventionalTreatment
Connecticut Children's Medical Center
~15 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Fetoscopic Endoluminal Tracheal Occlusion (FETO)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of neonatal survivors at time of discharge
Measured over Discharge from the hospital, an expected average of 12 weeks.
Congenital Diaphragmatic Hernias
1 sites across 1 states
Connecticut1
  • Timothy Crombleholme, MD · PRINCIPAL_INVESTIGATOR · Connecticut Children's Medical Center

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Eligibility criteria

Inclusion

Pregnant women age 18 years and older, who are able to consent
Singleton pregnancy
Normal Karyotype
Fetal Diagnosis of Isolated Left CDH with liver up
Gestation at enrollment prior to 29 wks plus 6 days
SEVERE pulmonary hypoplasia with Ultra Sound O/E LHR \< 25%

Exclusion

Pregnant women \<18 years of age.
Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
Technical limitations precluding fetoscopic surgery
Rubber latex allergy
Preterm labor, cervix shortened (\<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
Psychosocial ineligibility, precluding consent
Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 25%
Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care
  • Percent of neonatal survivors at time of dischargeDischarge from the hospital, an expected average of 12 weeks.

    Feasibility, safety, and survival rates of the FETO procedure