Balloon in the womb may ease lung pressure in severe birth defect

NCT ID NCT03980717

First seen Feb 06, 2026 · Last updated Jun 23, 2026 · Updated 24 times

Summary

This study tests a procedure called FETO, where a tiny balloon is placed in the fetus's windpipe to help the lungs grow. It focuses on babies with severe congenital diaphragmatic hernia (CDH), a condition where abdominal organs move into the chest and stunt lung development. Researchers want to see if FETO helps resolve pulmonary hypertension (high blood pressure in the lungs) by age 1. The study will compare 40 babies who get FETO with 40 who do not.

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Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Texas Childrens Hospital

    RECRUITING

    Houston, Texas, 77030, United States

    Contact

    Contact

    Contact

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    Contact

    Contact

    Contact Phone: •••-•••-••••

    Contact Phone: •••-•••-••••

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What this could mean

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

Active substance

Goldbal detachable balloon device (FETO)

What this could lead to

If successful, FETO could become a standard way to improve lung development and reduce dangerous lung blood pressure in babies with severe CDH, potentially increasing survival.

What could go wrong

This is a small, early-stage prospective study (80 participants) comparing outcomes to a non-randomized control group. The procedure carries risks of preterm labor or balloon-related complications, and benefits are not yet proven.

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.