Balloon in the womb could save babies with rare birth defect

NCT ID NCT06179472

Ongoing Disease control Sponsor: Inna Lobeck Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a procedure called FETO, where a tiny balloon is placed in the windpipe of unborn babies with severe congenital diaphragmatic hernia (CDH). The balloon helps the lungs grow before birth and is later removed. Researchers want to see if this improves survival and reduces the need for breathing machines after delivery. The trial involves 20 pregnant people and will follow the babies for two years.

What this could mean

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

Active substance: BALT Goldbal2 detachable balloon (device)
What this could lead to: If successful, this procedure could significantly increase survival and reduce severe lung and heart complications in babies with congenital diaphragmatic hernia.
What could go wrong: This is a small, single-center trial with only 20 participants, so results may not apply broadly. The procedure carries risks of premature delivery or balloon-related complications.

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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

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

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