Balloon in the womb: new hope for babies with severe birth defect?
NCT ID NCT03138863
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a procedure called FETO for unborn babies with a severe form of congenital diaphragmatic hernia (CDH), where the diaphragm has a hole and the lungs don't grow well. Doctors place a tiny balloon in the baby's windpipe to block it, which may help the lungs expand and grow. The trial will enroll 10 pregnant women to see if the procedure is safe and can be done successfully.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- BALT GoldbBAL2 Detachable Balloon and catheter system
- What this could lead to
- If successful, this procedure could improve lung growth and survival in babies with severe congenital diaphragmatic hernia.
- What could go wrong
- This is a very small early study (10 participants) focused on safety and feasibility. The procedure carries risks like preterm labor, infection, or premature balloon removal. It may not improve outcomes.
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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Mayo Clinic
TERMINATEDRochester, Minnesota, 55905, United States
-
University of Miami
RECRUITINGMiami, Florida, 33136, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Teens' sports struggles after rare birth defect surgery: study seeks answers
- New trial could change how doctors help CDH babies at birth
- Pioneering fetal surgery aims to save babies born with a hole in their diaphragm