Fetal tracheal balloon procedure to help lungs grow in severe congenital diaphragmatic hernia
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Right and Left Congenital Diaphragmatic Hernia (CDH)
This will try a temporary tracheal balloon (FETO) in pregnant women carrying a fetus with severe left or right congenital diaphragmatic hernia to see if it helps the lungs grow and is safe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT03674372 on ClinicalTrials.gov |
What this trial studies
This interventional protocol places a balloon in the fetal trachea via fetoscopy to block airway egress and stimulate lung growth, with a second procedure to remove the device before birth. Eligibility focuses on singleton pregnancies with isolated left or right CDH, liver-up, normal karyotype, and severe pulmonary hypoplasia defined by O/E LHR thresholds, enrolled before 29 weeks and 6 days gestation. The team monitors the pregnancy while the balloon remains in place and performs planned balloon release and postnatal follow-up including neonatal respiratory support as needed. The goal is to increase lung volume prenatally so newborns have improved lung function and survival after delivery.
Who should consider this trial
Good fit: Pregnant women aged 18 or older with a singleton fetus diagnosed with isolated left or right CDH with liver-up, normal fetal karyotype, and severe pulmonary hypoplasia (L-sided O/E LHR <25% or R-sided O/E LHR <45%) enrolled before 29 weeks 6 days are the intended candidates.
Not a fit: Pregnancies with milder CDH, chromosomal abnormalities, multiple gestation, advanced gestational age beyond the enrollment window, or maternal contraindications to fetoscopy are unlikely to benefit.
Why it matters
Potential benefit: If successful, fetal tracheal occlusion could increase lung growth before birth and improve newborn survival and respiratory outcomes.
How similar studies have performed: Prior case series and multicenter trials of FETO have shown increased fetal lung growth and improved survival for selected severe CDH cases, though outcomes and risks vary across studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women age 18 years and older, who are able to consent * Singleton pregnancy Fetal * Normal Karyotype * Fetal Diagnosis of Isolated Left or Right CDH with liver up * Gestation at enrollment prior to 29 wks plus 6 days * SEVERE pulmonary hypoplasia with Ultra Sound L-sided O/E LHR \< 25% or R-sided O/E LHR \<45% Exclusion Criteria: * 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 * Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care
Where this trial is running
Aurora, Colorado
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Elizabeth Torres
- Email: elizabeth.torres@childrenscolorado.org
- Phone: 720-777-1661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.