Tiny balloon inside womb could help babies breathe

NCT ID NCT04052828

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested a procedure called FETO, where a tiny balloon is placed in the windpipe of an unborn baby with severe congenital diaphragmatic hernia (CDH). The goal was to see if the balloon could be safely placed and removed to help the lungs grow. Four pregnant women participated, and the balloon was inserted between 27 and 29 weeks of pregnancy and removed around 34 weeks.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

Goldballoon Detachable Balloon (GOLDBAL2) with Delivery Microcatheter

What this could lead to

If successful, this procedure could improve lung growth in fetuses with severe CDH, potentially increasing survival after birth.

What could go wrong

This is a very small pilot trial with only 4 participants, so results may not apply widely. The procedure carries risks like preterm labor or balloon complications.

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

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States