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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

congenital diaphragmatic hernia pulmonary hypoplasia

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