Balloon in the womb: new hope for babies with underdeveloped lungs?

NCT ID NCT05962346

Recruiting now Disease control Sponsor: Mauro H. Schenone Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests a procedure called FETO, where a tiny balloon is placed in the fetus's windpipe to encourage lung growth. It is for pregnancies where the baby has severe left congenital diaphragmatic hernia (CDH) and very small lungs. The study will enroll 20 participants to see if the balloon can be safely placed and removed, and to measure lung growth and 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: BALT GOLDBALL 2 detachable latex balloon
What this could lead to: If successful, this procedure could improve lung development in fetuses with severe CDH, potentially increasing survival after birth.
What could go wrong: This is a small pilot trial (20 participants) focused on safety and technical success, not yet proven to improve outcomes. Risks include preterm labor, membrane rupture, and other maternal 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

Mayo Clinic Minnesota
RECRUITING

Rochester, Minnesota, 55905, United States

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