Fetal Endotracheal Occlusion (FETO) in Severe and Extremely Severe Congenital Diaphragmatic Hernia (FETO)
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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: Open Label |
| Official Title: | A Prospective Study of the Effectiveness of Fetal Endotracheal Occlusion (FETO) in the Management of Severe and Extremely Severe Congenital Diaphragmatic Hernia |
- Feasibility [ Time Frame: Study Duration ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 15 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | December 2021 |
| Estimated Primary Completion Date: | December 2016 (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:
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Detailed Description:
Enrollment
Women carrying fetuses with severe or extremely severe CDH and a normal karyotype will undergo routine clinical evaluation. The fetuses will be 27+0/7 to 29+6/7 weeks of gestational age for severe CDH and can be as early as 22+0/7 weeks gestational age for those deemed as "extremely severe" cases of CDH. They will have ultrasound and/or MRI evaluation to rule out other anomalies, calculation of the LHR from ultrasound measurements, echocardiography, and detailed obstetric/perinatal consultation. Patients who meet the eligibility criteria will be extensively counseled, and those who wish to participate will provide written, informed consent for the study.
Procedure
The procedure will be performed under spinal anesthesia or local anesthesia with intravenous sedation. The technique of fetal endoscopic tracheal occlusion has been described. Using standard technique, a cannula loaded with a pyramidal trocar will be inserted into the amniotic cavity and a fetoscope or flexible operating endoscope will be passed through the cannula into the amniotic fluid. The scope will be guided into the fetal larynx either through a nostril and then via the nasal passage or through the fetal mouth, and then through the fetal vocal cords with the aid of both direct vision through the scope and cross-sectional ultrasonographic visualization. A detachable latex balloon will be placed in the fetal trachea midway between the carina and the vocal cords. The balloon will be inflated with isosmotic contrast material so that it fills the fetal trachea.
Postoperative
The mothers will be discharged once stable. Serial measurements of sonographic lung volume and LHR will begin within 24-48 hours following surgery and continue weekly by targeted ultrasound evaluation. Amniotic fluid level and membrane status will also be monitored at weekly intervals. Comprehensive ultrasonography for fetal growth will be performed every four weeks. All discharged patients will stay within 30 minutes of TCH to permit standardized postoperative management and emergent retrieval of the balloon in the event of preterm labor or premature rupture of membranes prior to the scheduled removal.
Balloon retrieval will be planned at between 32+0/7 and 34+6/7 weeks at the discretion of the FETO center. The patient will need to commit to remaining in 30 minutes of Texas Children's Hospital Pavilion for Women until the balloon is retrieved.
After removal of the balloon, patients will have the choice of delivering at Texas Children's Hospital- Women's Pavilion with the CDH managed and repaired at TCH, or returning to their obstetrician for delivery with subsequent repair of the CDH by the pediatric surgeons at their referring facility. Given the severity of the CDH, the baby will need to be delivered in a facility that has the capability of immediate pediatric surgery services.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
- Patient is a pregnant woman between 18 and 45 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 equal to or greater than 0.71 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00881660
| Contact: Michael Belfort, MD PhD | 832 826-7375 | belfort@bcm.edu | |
| Contact: Alicia Brown, MPH | 713-798-8949 | aabrown@bcm.edu |
| United States, Texas | |
| Baylor College of Medicine/Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Michael A. Belfort, MD PhD 832-826-7375 belfort@bcm.edu | |
| Contact: Anne McCombs 713-798-7888 anne.mccombs@bcm.edu | |
| Principal Investigator: Michael A. Belfort, MD PhD | |
| Sub-Investigator: Rodrigo Ruano, MD, Ph | |
| Sub-Investigator: Oluyinka Olutoye, MB, ChB, PhD | |
| Sub-Investigator: Olutoyin Olutoye, MB, ChB | |
| Sub-Investigator: Darrell Cass, MD | |
| Sub-Investigator: Stephen Welty, MD | |
| Sub-Investigator: Christopher Cassady, MD | |
| Sub-Investigator: Timothy Lee, MD | |
| Sub-Investigator: Alireza Abdollah Shamshirsaz, MD | |
| Sub-Investigator: Wesley Lee, MD | |
| 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: | July 19, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Baylor College of Medicine:
|
Fetal Tracheal Occlusion congenital diaphragmatic hernia FETO plug-unplug |
Goldvalve balloon Severe Congenital Diaphragmatic Hernia Extremely Severe Congenital Diaphragmatic Hernia |
Additional relevant MeSH terms:
|
Hernia Hernia, Diaphragmatic Hernias, Diaphragmatic, Congenital Pathological Conditions, Anatomical Congenital Abnormalities |
ClinicalTrials.gov processed this record on September 27, 2016