A Prospective Study of the Effectiveness of Fetal Endotracheal Occlusion (FETO) in the Management of Severe and Extremely Severe Congenital Diaphragmatic Hernia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 2-year Survival
研究概览
简要总结
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.
详细描述
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. If, upon evaluation, the baby cannot be accessed through the way just described above, the uterus will be accessed through an incision in the belly (called a laparotomy). A laparotomy is a surgical technique that makes an incision in the abdomen. After the incision has been made, the uterus will be temporarily repositioned externally. The baby will then be accessed using the fetoscope and ultrasound, as described above. The laparotomy will only be done if the baby cannot be reached and repositioned to a more favorable one by doing external maneuvers (called external version) for the FETO procedure.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
2-year Survival
时间窗: 2 years after childbirth.
To assess two-year neonatal survival following FETO.
次要结局
- Maternal Outcomes- Maternal Morbidity-length of hospitalization(Up to 6 weeks postpartum)
- Neonatal/Child outcomes- gastrointestinal morbidity(Up to 2 years of age)
- Neonatal/Child outcomes- Neurodevelopmental(Up to 18 years of age)
- Maternal Outcomes- Maternal Morbidity- Rupture of membranes(Up to 6 weeks postpartum)
- Neonatal/Child outcomes- Pulmonary Morbidity- ventilatory support(Up to 2 years of age)
- Neonatal/Child outcomes- recurrent infection(Up to 18 years of age)
- Successful completion of surgical procedures/balloon placement(Up to 10 weeks.)
- Maternal Outcomes- Maternal Morbidity-incidence of cesarean section(Up to 6 weeks postpartum)
- Maternal Outcomes- Maternal Morbidity- length of hospitalization after UNPLUG procedure(Up to 6 weeks postpartum)
- Maternal Outcomes- Maternal Morbidity- vaginal bleeding(Up to 6 weeks postpartum)
- Maternal Outcomes- Maternal Morbidity- oligohydramnios(Up to 6 weeks postpartum)
- Neonatal/Child outcomes- repeated hospitalization(Up to 18 years of age)
- Maternal Outcomes- Maternal Morbidity-incidence of preterm delivery(Up to 6 weeks postpartum)
- Maternal Outcomes- Maternal Morbidity- Placental abruption(Up to 6 weeks postpartum)
- Maternal Outcomes- Maternal Morbidity- chorioamnionitis(Up to 6 weeks postpartum)
- Neonatal/Child outcomes- Pulmonary Morbidity- Supplemental oxygen(Up to 2 years of age)
- Neonatal/Child outcomes-neurologic morbidity(Up to 2 years of age)
- Neonatal/Child outcomes- Survival to discharge from the hospital(Up to 2 years of age)
- Neonatal/Child outcomes- Duration of hospitalization.(Up to 2 years of age)
- Neonatal/Child outcomes- need for supplemental oxygen(Up to 18 years of age)
- Neonatal/Child outcomes- Pulmonary Morbidity - ECMO(Up to 2 years of age)
研究者
Michael A Belfort
Chairman and Professor
Baylor College of Medicine