Clin2
NCT05962346Possibly a fitRecruiting

Pregnancy balloon procedure for severe left diaphragmatic hernia

Congenital Diaphragmatic Hernia

Part of Genetic & congenital clinical trials.

This trial studies whether placing a small balloon in the fetus’s airway during pregnancy (a procedure called FETO) can improve lung development and outcomes for babies with severe left congenital diaphragmatic hernia. You may be considered if the condition is isolated, very severe, and you can meet specific timing and follow-up requirements.

Summary written for real people, not researchers, by Clin2.

Phase
N/A
Enrollment
20 people
Ages
18 years to 50 years
Study type
Interventional

Who can take part

  • You’re pregnant with one baby (not twins or more).
  • Tests suggest the baby’s chromosomes look normal (karyotype or microarray; late results by FISH may be allowed).
  • The baby has isolated severe left diaphragmatic hernia, with ultrasound measurement showing very small lungs (O/E LHR under 25%).
  • You must start the trial visit before 29 weeks 6 days, and the balloon procedure must happen around 27 to 29 weeks 6 days.
  • You can travel and stay near Mayo Clinic in Rochester for follow-up, and you have a support person available to stay with you during the pregnancy.
  • Your care team confirms the balloon procedure is safe and technically possible in your specific case.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

Similar studies

Other trials that look related to this one.

NCT07564297Enrolling by invitation
Long-term outcomes after fetal lung surgery for diaphragmatic hernia

This study follows babies born after a special fetal surgery (FETO) that places a temporary balloon in the baby's windpipe to help the lungs grow when they have a diaphragmatic hernia—a hole in the muscle that separates the chest from the belly. Researchers want to understand how these children do over time after this procedure.

Rochester, Minnesota
NCT06884423Recruiting
Balloon treatment for severe diaphragmatic hernia in unborn babies

This trial tests if placing a temporary balloon in the baby's windpipe before birth can improve survival for babies with a severe form of a diaphragmatic hernia. It is for pregnant women carrying a single baby with a left-sided hernia that is more severe or a right-sided hernia, and whose liver is up in the chest.

Philadelphia, Pennsylvania
NCT05421676Recruiting
Fetal airway procedure for severe congenital diaphragmatic hernia

This trial studies a fetal procedure called FETO that places a small balloon in the baby’s windpipe to help the lungs grow in severe congenital diaphragmatic hernia (CDH). It may help babies with very small lung development after birth, but you must meet specific pregnancy, genetic, and safety requirements.

Sacramento, California
NCT05450653Recruiting
FETO balloon treatment for severe birth diaphragm hernia

This trial tests a special pregnancy procedure called FETO to help babies born with severe congenital diaphragm hernia (CDH) breathe better after birth. It may help by improving lung growth, but it requires close follow-up at a Chicago fetal center.

Chicago, Illinois
NCT07187206Recruiting· Phase 3
Fetoscopic surgery for severe diaphragmatic hernia

This trial tests if a special surgery (FETO) done while the baby is still in the womb can improve survival for babies with a severe form of congenital diaphragmatic hernia (CDH). The surgery places a small balloon in the baby's windpipe to help the lungs grow. We are looking for pregnant women whose baby has a left-sided CDH with a lung-to-head ratio (LHR) less than 30%, or a right-sided CDH with LHR less than 45%, and whose liver is herniated into the chest.

Cincinnati, Ohio
NCT06739356Recruiting
Balloon treatment study for severe diaphragmatic hernia in babies

This study tests a fetal surgery (fetoscopic tracheal balloon placement) to help lungs grow in babies with a severe hole in the diaphragm. It focuses on pregnancies where the liver is also in the chest and lung size is very small.

Houston, Texas

Hear when a new Congenital Diaphragmatic Hernia trial opens

We’ll email you when one opens — at most once a week, no account needed, unsubscribe anytime.