Fetal Endoscopic Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) NCT3138863
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Frequency of unplanned balloon removal
研究概览
简要总结
The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy
- •Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks.
- •Isolated Left CDH with liver up
- •Gestation age at enrollment prior to 29 wks plus 6 days severe pulmonary hypoplasia with ultrasound (US) O/E lung area to head circumference ratio (LHR) < 25% (measured at 180 to 296 weeks) at the time of surgery; O/E LHR 25% to <30% (measured at 300 to 316 weeks) at time of surgery.
- •Gestational age at FETO procedure with O/E LHR <25% at 27 weeks 0 days to 29 weeks 6 days; with O/E LHR 25% to <30% at 30 weeks 0 days to 31 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
- •Patient meets psychosocial criteria
排除标准
- •Multi-fetal pregnancy
- •History of natural rubber latex allergy
- •Preterm labor, cervix shortened (<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
- •Psychosocial ineligibility, precluding consent:
- •Inability to reside within 30 minute drive of our hospital, and inability to comply with the travel for the follow-up requirements of the trial
- •Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at our institution.
- •Right sided CDH or bilateral CDH, isolated left sided with O/E LHR ≥30% (measured at 180 to 295 weeks) as determined by ultrasound
- •Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. No cases will be removed post hoc if abnormalities are discovered in the course of postoperative monitoring
- •Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
- •History of incompetent cervix with or without cerclage
- •Placental abnormalities (previa, abruption, accrete) known at time of enrollment
- •Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
- •Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
- •Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
研究组 & 干预措施
FETO Group
Participants undergoing fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system.
干预措施: BALT GoldbBAL2 Detachable Balloon (Device)
FETO Group
Participants undergoing fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system.
干预措施: Catheter System (Device)
结局指标
主要结局
Frequency of unplanned balloon removal
时间窗: Up to 34 weeks gestation
The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)
Number of incidences of maternal complications
时间窗: Up to 41 weeks gestation
Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis
Number of participants with maternal complications
时间窗: Up to 41 weeks gestation
Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis
Operative time
时间窗: Up to 34 weeks gestation
FETO placement and release operative times reported in minutes
Number of successfully completed FETO procedures
时间窗: Up to 34 weeks gestation
The number of successful placement and removal of balloon during FETO procedure
Gestational Age at Delivery
时间窗: Up to 41 weeks gestation
Gestation Age reported at time of delivery
次要结局
- Fetal Lung Growth as measured via Fetal Lung Volume(Up to 41 weeks gestation)
- Number of newborns reported at each oxygen dependency grading(Up to 24 months post partum)
- Number of days of Diaphragmatic Repair(Up to 24 months post partum)
- Fetal Lung Growth as measured via LHR(Up to 41 weeks gestation)
- Number of occurrence of severe pulmonary hypertension(Up to 24 months post partum)
- Number of days in neonatal intensive care unit(Up to 24 months post partum)
- Number of infants requiring the use of patch or muscle flap(Up to 24 months post partum)
- Fetal survival(Up to 24 months post partum)
- Number of days of ventilator support(Up to 24 months post partum)
- Number of participants at each route of delivery(Day 1 (post partum))
- Number of infants requiring ECMO Support(Up to 24 months post partum)
- Number of days of maternal hospitalization(Up to 24 months post partum)
- Number of infants reporting presence of complications(Up to 24 months post partum)
研究者
Rodrigo Ruano
Professor and Chief of MFM Division
University of Miami