Clin2
NCT02986087Possibly a fitRecruiting

FETO balloon procedure for severe congenital diaphragmatic hernia

Congenital Diaphragmatic HerniaPulmonary HypoplasiaPulmonary; Hypertension

Part of Genetic & congenital, Heart & circulation, Lungs & breathing clinical trials.

This trial studies a fetal procedure called FETO (placing a small balloon in the baby’s windpipe) to help severe congenital diaphragmatic hernia babies develop better lungs before birth. It may help some babies whose scans suggest very limited lung growth, but it requires specific timing and pregnancy conditions.

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

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

Who can take part

  • You must have an isolated congenital diaphragmatic hernia (CDH) with the liver sitting higher than usual (“liver-up”).
  • The baby’s lung development on ultrasound must be very limited (measured by LHR below set cutoffs) and match the specific timing windows for the procedure.
  • You must be at least 18 years old, and you must be able to have the procedure within the listed weeks of pregnancy.
  • Your pregnancy must be a single baby (not twins or more).
  • You must have normal chromosome testing (karyotype or FISH) and a normal fetal echocardiogram (no major heart issues).
  • Your family must be able to stay in the Cincinnati area for the rest of the pregnancy and meet psychosocial requirements; you must also have declined pregnancy termination at less than 24 weeks.

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.

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