Balloon in the womb may ease lung pressure in severe birth defect
NCT ID NCT03980717
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a procedure called FETO, where a tiny balloon is placed in the fetus's windpipe to help the lungs grow. It focuses on babies with severe congenital diaphragmatic hernia (CDH), a condition where abdominal organs move into the chest and stunt lung development. Researchers want to see if FETO helps resolve pulmonary hypertension (high blood pressure in the lungs) by age 1. The study will compare 40 babies who get FETO with 40 who do not.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Goldbal detachable balloon device (FETO)
- What this could lead to
- If successful, FETO could become a standard way to improve lung development and reduce dangerous lung blood pressure in babies with severe CDH, potentially increasing survival.
- What could go wrong
- This is a small, early-stage prospective study (80 participants) comparing outcomes to a non-randomized control group. The procedure carries risks of preterm labor or balloon-related complications, and benefits are not yet proven.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Texas Childrens Hospital
RECRUITINGHouston, Texas, 77030, United States
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