Plain-English translation of NCT03138863 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This trial is testing a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) for babies diagnosed with severe congenital diaphragmatic hernia — a birth defect where the diaphragm (the muscle that helps you breathe) doesn't form properly, allowing organs to move into the chest and crowd the lungs. The procedure involves inserting a tiny balloon into the baby's airway during pregnancy to temporarily block it, which may help the lungs grow larger and stronger before birth. Researchers want to see if this treatment is safe and effective for babies with the most severe lung underdevelopment.
Severe congenital diaphragmatic hernia can result in dangerously underdeveloped lungs that make it very hard for babies to breathe after birth. Current treatments don't always work well enough, so doctors are testing this new procedure to see if it can help babies' lungs grow better before they are born, giving them a better chance of survival and healthier breathing after delivery.
You likely qualify if…
You likely don't qualify if…
If you enroll, you will undergo a minimally invasive fetal surgery performed by a specialist using a tiny camera and instruments to place a small balloon in your baby's airway. The procedure typically takes place between 27 and 31 weeks of pregnancy at a specialized fetal treatment center. You will need to remain near the hospital and attend regular follow-up appointments for monitoring throughout the rest of your pregnancy, with close ultrasound and clinical checks to ensure both you and your baby are doing well.
AI-generated summary from trial data · Jun 22, 2026 · Not medical advice
United States
Sponsor
Rodrigo Ruano
Enrollment target
~10 participants
Started
May 2024
Primary completion
December 2027
Age range
18 Years – 50 Years
Sex
Female only
Last updated on clinicaltrials.gov in February 2026.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Rodrigo A Ruano, MD, Ph.D
University of Miami
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.