Tiny balloon inside womb could help babies breathe

NCT ID NCT04052828

Completed Disease control Sponsor: Dr Erin Perrone Source: ClinicalTrials.gov ↗

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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.

CONGENITAL DIAPHRAGMATIC HERNIA

Contacts and locations

Locations

University of Michigan

Ann Arbor, Michigan, 48109, United States

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