Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH

Recruiting now · Not applicable

Conditions studied: Congenital Diaphragmatic Hernias

In brief

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

Key facts

Study ID

NCT02530073

Run by

Connecticut Children's Medical Center

People needed

15

Starts

2015-09-01

Expected to finish

2030-08-01

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pregnant women age 18 years and older, who are able to consent
• Singleton pregnancy
• Fetal
• 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%

You may not qualify if…

• 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

Where it is running

• Connecticut Children's Medical Center — Hartford, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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