Fetal tracheal balloon procedure to help lungs grow in severe congenital diaphragmatic hernia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting

Study contacts

• Study coordinator: Elizabeth Torres
• Email: elizabeth.torres@childrenscolorado.org
• Phone: 720-777-1661

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• Fetoscopic balloon (FETO) for severe left and right congenital diaphragmatic hernia — long-term outcomes

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.