Balloon in the womb: new hope for babies with underdeveloped lungs?
NCT ID NCT02549820
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tests a procedure called FETO in 14 unborn babies with severe left congenital diaphragmatic hernia (CDH), a birth defect where abdominal organs push into the chest and stunt lung growth. Doctors place a tiny balloon in the baby's windpipe via fetoscopy to trap lung fluid and encourage lung expansion. The goal is to see if the balloon can be safely placed and removed, potentially improving survival after birth.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- GoldBAL2 Detachable Balloon and delivery catheter (fetoscopic endoluminal tracheal occlusion device)
- What this could lead to
- If successful, this procedure could help babies with severe CDH survive by allowing their lungs to grow before birth.
- What could go wrong
- This is a very small pilot study (14 participants) testing feasibility, not effectiveness. The procedure carries risks for both mother and fetus, including premature balloon removal or complications from the fetoscopic surgery.
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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
-
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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