Fetal Endotracheal Occlusion (FETO) in Severe Congenital Diaphragmatic Hernia
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 15 FETO procedures on fetuses diagnosed prenatally with severe and extremely severe CDH.
|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 Congenital Diaphragmatic Hernia|
- Feasibility [ Time Frame: Study Duration ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: Fetal Endotracheal Occlusion
Placement of the Goldvalve tracheal balloon using the plug/unplug method.
Device: Goldvalve Detachable Balloon
Between 22+0/7 - 29+ 6/7 weeks gestation, placement of the Goldvalve detachable balloon. At 34 weeks gestation (or a maximum of 10 weeks if placed prior to 24 weeks gestational age), removal of the balloon.
Women carrying fetuses with left-sided severe or extremely severe CDH and a normal karyotype will undergo evaluation. The fetuses will be 27+0/7 to 29+6/7 weeks of gestational age for severe CDH and can be as early at 22+0/7 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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00881660
|United States, Texas|
|Baylor College of Medicine/Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael Belfort, MD, PhD||Baylor College of Medicine/Texas Children's Hospital|