Balloon in the womb: new hope for babies with rare birth defect?

NCT ID NCT06946576

Not yet recruiting Disease control Sponsor: Oregon Health and Science University Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase III trial tests a procedure called FETO for severe congenital diaphragmatic hernia (CDH), where the diaphragm is incomplete and organs move into the chest. Doctors place a temporary balloon in the baby's windpipe before birth to help the lungs grow. The study will compare survival and long-term health of 80 babies who get FETO versus those who receive standard care.

What this could mean

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

Active substance: Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure with a detachable balloon
What this could lead to: If successful, this procedure could significantly increase survival rates for babies with severe congenital diaphragmatic hernia, offering a new treatment option before birth.
What could go wrong: This is an invasive fetal procedure with risks of complications for both mother and baby. The trial is still recruiting, and long-term outcomes are not yet known.

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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

Oregon Health & Science University

Portland, Oregon, 97239, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.