Percutaneous Endoscopic Tracheal Plug/Unplug for CDH
STATUS: Active, not recruiting
University of California, San Francisco
Congenital diaphragmatic hernia is an anatomically simple birth defect in which contents of
the fetal abdomen migrate into the chest due to incomplete formation of the diaphragm.
Herniation of viscera into the chest prevents the fetal lungs from developing and growing to
normal size. In the most severe cases, there is significant morbidity and mortality at
birth. For these fetuses, fetal intervention may improve outcomes by enabling the lungs to
grow enough in utero that they are capable of sustaining life after birth. This unblinded,
non-randomized trial will assess the safety and efficacy of the use of the Goldvalve balloon
and MiniTorquer microcatheter to perform percutaneous temporary tracheal occlusion to treat
severe CDH in utero. The primary outcome variable will be fetal lung growth due to
successful 'plugging/unplugging' of the trachea, as determined by serial lung-head ratio
(LHR) measurements. Secondary outcome variables include maternal, fetal and neonatal
variables, specifically neonatal survival at 90 days of life. For infants who survive
beyond 90 days post-delivery, their families will be offered follow-up (up to 2 years of age
and possibly beyond) in the Long-term Infant-to-Adult Follow-up Evaluation (LIFE) Clinic at
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percutaneous Endoscopic Tracheal Plug/Unplug for Congenital Diaphragmatic Hernia
Ages Eligible for Study: 18 Years - N/A
Genders Eligible for Study
Location and Contact Information
University of California, San Francisco Fetal Treatment Center ()
San Francisco, California
- Jani JC, Nicolaides KH, Gratacós E, Vandecruys H, Deprest JA; FETO Task Group. Fetal lung-to-head ratio in the prediction of survival in severe left-sided diaphragmatic hernia treated by fetal endoscopic tracheal occlusion (FETO). Am J Obstet Gynecol. 2006 Dec;195(6):1646-50. Epub 2006 Jun 12.
- Doné E, Gucciardo L, Van Mieghem T, Jani J, Cannie M, Van Schoubroeck D, Devlieger R, Catte LD, Klaritsch P, Mayer S, Beck V, Debeer A, Gratacos E, Nicolaides K, Deprest J. Prenatal diagnosis, prediction of outcome and in utero therapy of isolated congenital diaphragmatic hernia. Prenat Diagn. 2008 Jul;28(7):581-91. doi: 10.1002/pd.2033. Review.
- Cortes RA, Keller RL, Townsend T, Harrison MR, Farmer DL, Lee H, Piecuch RE, Leonard CH, Hetherton M, Bisgaard R, Nobuhara KK. Survival of severe congenital diaphragmatic hernia has morbid consequences. J Pediatr Surg. 2005 Jan;40(1):36-45; discussion 45-6.
- Keller RL, Hawgood S, Neuhaus JM, Farmer DL, Lee H, Albanese CT, Harrison MR, Kitterman JA. Infant pulmonary function in a randomized trial of fetal tracheal occlusion for severe congenital diaphragmatic hernia. Pediatr Res. 2004 Nov;56(5):818-25. Epub 2004 Aug 19.
- Harrison MR, Keller RL, Hawgood SB, Kitterman JA, Sandberg PL, Farmer DL, Lee H, Filly RA, Farrell JA, Albanese CT. A randomized trial of fetal endoscopic tracheal occlusion for severe fetal congenital diaphragmatic hernia. N Engl J Med. 2003 Nov 13;349(20):1916-24.
- Harrison MR, Albanese CT, Hawgood SB, Farmer DL, Farrell JA, Sandberg PL, Filly RA. Fetoscopic temporary tracheal occlusion by means of detachable balloon for congenital diaphragmatic hernia. Am J Obstet Gynecol. 2001 Sep;185(3):730-3.
- Ruano R, Ali RA, Patel P, Cass D, Olutoye O, Belfort MA. Fetal endoscopic tracheal occlusion for congenital diaphragmatic hernia: indications, outcomes, and future directions. Obstet Gynecol Surv. 2014 Mar;69(3):147-58. doi: 10.1097/OGX.0000000000000045.
- Doné E, Gratacos E, Nicolaides KH, Allegaert K, Valencia C, Castañon M, Martinez JM, Jani J, Van Mieghem T, Greenough A, Gomez O, Lewi P, Deprest J. Predictors of neonatal morbidity in fetuses with severe isolated congenital diaphragmatic hernia undergoing fetoscopic tracheal occlusion. Ultrasound Obstet Gynecol. 2013 Jul;42(1):77-83. doi: 10.1002/uog.12445.
Study ID Numbers: 10-01765TO CDH
Date study started: October 2008
For additional information, visit ClinicalTrials.gov.
ClinicalTrials.gov processed this data on April 16, 2015
This directory includes clinical trials that involve researchers at UCSF Medical Center. The information was obtained from ClinicalTrials.gov, a database of the U.S. National Institutes of Health.