Fetal Endotracheal Occlusion (FETO) in Severe and Extremely Severe Congenital Diaphragmatic Hernia (FETO)
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| ClinicalTrials.gov Identifier: NCT00881660 |
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Recruitment Status
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Recruiting
First Posted
: April 15, 2009
Last Update Posted
: June 26, 2017
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Congenital Diaphragmatic Hernia | Device: Goldballoon Detachable Balloon and delivery microcatheter | Not Applicable |
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| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| 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 |
| Study Start Date : | March 2010 |
| Estimated Primary Completion Date : | December 2017 |
| Estimated Study Completion Date : | December 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Fetal Endotracheal Occlusion
Placement of the Goldballoon tracheal balloon using the plug/unplug method.
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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:
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- Feasibility [ Time Frame: Study Duration ]
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| Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00881660
| Contact: Michael Belfort, MD PhD | 832 826-7375 | belfort@bcm.edu | |
| Contact: Wyoniquea D Rahming, MBA | 832-826-7345 | rahming@bcm.edu |
| 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 | |
| Principal Investigator: | Michael Belfort, MD, PhD | Baylor College of Medicine/Texas Children's Hospital |
Publications of Results:
Other 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 |
| First Posted: | April 15, 2009 Key Record Dates |
| Last Update Posted: | June 26, 2017 |
| Last Verified: | June 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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:
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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:
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Hernia Hernia, Diaphragmatic Hernias, Diaphragmatic, Congenital Pathological Conditions, Anatomical Congenital Abnormalities |