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Fetal Endotracheal Occlusion (FETO) in Severe and Extremely Severe Congenital Diaphragmatic Hernia (FETO)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Michael Belfort, Baylor College of Medicine
Sponsor:
Collaborators:
Baylor College of Medicine
Texas Children's Hospital
Information provided by (Responsible Party):
Michael Belfort, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00881660
First received: April 13, 2009
Last updated: June 22, 2017
Last verified: June 2017
  Purpose

Congenital diaphragmatic hernia (CDH) occurs when the diaphragm fails to fully fuse and leaves a portal through which abdominal structures can migrate into the thorax. In the more severe cases, the abdominal structures remain in the thoracic cavity and compromise the development of the lungs. Infants born with this defect have a decreased capacity for gas exchange; mortality rates after birth have been reported between 40-60%. Now that CDH can be accurately diagnosed by mid-gestation, a number of strategies have been developed to repair the hernia and promote lung tissue development.

Fetal tracheal occlusion is one technique that temporarily closes the herniated area with the Goldvalve balloon to allow the lungs to develop and increase survival at birth. This is a pilot study of a cohort of fetuses affected by severe CDH that will undergo FETO to demonstrate the feasibility of performing the procedure, managing the pregnancy during the period of tracheal occlusion, and removal of the device prior to delivery at BCM/Texas Children's Hospital (TCH). It is anticipated that fetal tracheal occlusion plug-unplug procedure will improve mortality and morbidity outcomes as compared with current management, but this is not a primary endpoint of the feasibility study. We will perform 20 FETO procedures on fetuses diagnosed prenatally with severe and extremely severe CDH.


Condition Intervention
Congenital Diaphragmatic Hernia Device: Goldballoon Detachable Balloon and delivery microcatheter

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Device Feasibility
Official Title: A Prospective Study of the Effectiveness of Fetal Endotracheal Occlusion (FETO) in the Management of Severe and Extremely Severe Congenital Diaphragmatic Hernia

Resource links provided by NLM:


Further study details as provided by Michael Belfort, Baylor College of Medicine:

Primary Outcome Measures:
  • Feasibility [ Time Frame: Study Duration ]

Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fetal Endotracheal Occlusion
Placement of the Goldballoon tracheal balloon using the plug/unplug method.
Device: Goldballoon Detachable Balloon and delivery microcatheter
Between 27+0/7 - 29+ 6/7 weeks gestation for severe CDH and can be as early as 22+0/7 weeks gestational age for those deemed as "extremely severe" cases of CDH, placement of the Goldvalve detachable balloon. Balloon retrieval will be planned for between 32+0/7 and 34+6/7 weeks or no longer than 10 weeks after balloon placement at the discretion of the FETO center.
Other Names:
  • GOLDBAL4 or GOLDBAL2 Goldballoon
  • BALTACCIBDPE100 delivery microcatheter

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • Patient is a pregnant woman between 18 and 64 years of age
  • Singleton pregnancy
  • Confirmed diagnosis of severe or extremely severe left, right or bilateral CDH of the fetus

Severe CDH: -Fetal liver herniated into the left hemithorax -Lung-head ratio (LHR) is less than or equal to 1.0 calculated between 27+0/7 and 29+6/7 weeks' gestation

Extremely Severe CDH: -At least 1/3rd of the liver parenchyma herniated into the thoracic cavity -Lung-head ratio (LHR) is < 0.71 calculated between 22+0/7 and 29+6/7 weeks' gestation

  • Normal fetal echocardiogram or echocardiogram with a minor anomaly (such a small VSD) that in the opinion of the pediatric cardiologist will not affect postnatal outcome
  • Normal fetal karyotype
  • The mother must be healthy enough to have surgery
  • Patient provides signed informed consent that details the maternal and fetal risks involved with the procedure
  • Patient willing to remain in Houston for the duration following the balloon placement until delivery
  • Signed informed consent

EXCLUSION CRITERIA:

  • Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
  • Allergy to latex
  • Allergy or previous adverse reaction to a study medication specified in this protocol
  • Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor)
  • Fetal aneuploidy, known structural genomic variants, other major fetal anomalies, or known syndromic mutation
  • Suspicion of major recognized syndrome (e.g. Fryns syndrome) on ultrasound or MRI
  • Maternal BMI >35
  • High risk for fetal hemophilia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881660

Contacts
Contact: Michael Belfort, MD PhD 832 826-7375 belfort@bcm.edu
Contact: Wyoniquea D Rahming, MBA 832-826-7345 rahming@bcm.edu

Locations
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Michael A. Belfort, MD PhD    832-826-7375    belfort@bcm.edu   
Contact: Carmen Luna Marcos de La Penha    832-826-7713    penha@bcm.edu   
Principal Investigator: Michael A. Belfort, MD PhD         
Sub-Investigator: Oluyinka Olutoye, MB, ChB, PhD         
Sub-Investigator: Olutoyin Olutoye, MB, ChB         
Sub-Investigator: Chistopher Cassady, MD         
Sub-Investigator: Jimmy Espinoza, MD         
Sub-Investigator: Magdalena Sanz Cortes, MD         
Sub-Investigator: Timothy Lee, MD         
Sub-Investigator: Alireza Abdollah Shamshirsaz, MD         
Sub-Investigator: Wesley Lee, MD         
Sub-Investigator: Sundeep Keswani, MD         
Sponsors and Collaborators
Michael Belfort
Baylor College of Medicine
Texas Children's Hospital
Investigators
Principal Investigator: Michael Belfort, MD, PhD Baylor College of Medicine/Texas Children's Hospital
  More Information

Publications:

Responsible Party: Michael Belfort, Chairman and Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00881660     History of Changes
Other Study ID Numbers: H-28021
Study First Received: April 13, 2009
Last Updated: June 22, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Michael Belfort, Baylor College of Medicine:
Fetal Tracheal Occlusion
congenital diaphragmatic hernia
FETO plug-unplug
Goldvalve balloon
Severe Congenital Diaphragmatic Hernia
Extremely Severe Congenital Diaphragmatic Hernia
Goldbal balloon
FETO

Additional relevant MeSH terms:
Hernia
Hernia, Diaphragmatic
Hernias, Diaphragmatic, Congenital
Pathological Conditions, Anatomical
Congenital Abnormalities

ClinicalTrials.gov processed this record on June 26, 2017