Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion for Severe Left Congenital Diaphragmatic Hernia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Technical success of balloon retrieval procedure
研究概览
简要总结
The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).
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 or microarray. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
- •Isolated severe left CDH with O/E LHR < 25% )
- •Gestation age at enrollment prior to 29 wks plus 6 days.
- •Pulmonary hypoplasia with ultrasound O/E LHR < 25% (measured at 18 0/7 to 29 5/7 weeks) at the time of surgery.
- •Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
- •Patient meets psychosocial criteria: able to reside within 30 minutes of Mayo Clinic, Rochester and able to comply with the travel for the follow-up requirements of the trial; patient has a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Mayo Clinic
- •Patient is willing and able to give informed consent
- •Appropriate multi-disciplinary counseling performed with maternal-fetal medicine, neonatology, pediatric surgery, genetics, pediatric otolaryngology (ENT)
排除标准
- •Multi-fetal pregnancy
- •History of natural rubber latex allergy
- •Preterm labor, cervix shortened (<20 mm) at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor
- •Psychosocial ineligibility, precluding consent: inability to reside within 30 minutes of Mayo Clinic, Rochester 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 Mayo Clinic
- •Right sided CDH or bilateral CDH, isolated left sided with O/E LHR >25% measured at 18 0/7 to 29 6/7 weeks) as determined by ultrasound
- •Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram that will significantly worsen prognosis. No cases will be removed post hoc if abnormalities are discovered in the course of post-operative monitoring
- •Maternal contraindication to fetoscopic surgery
- •History of incompetent cervix with or without cerclage
- •Placental abnormalities (previa, abruption, accreta) 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.
- •Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality that will make the procedure technically unfeasible
- •No safe or technically feasible fetoscopic approach to balloon placement
- •Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
结局指标
主要结局
Technical success of balloon retrieval procedure
时间窗: Up to 34 weeks gestation
The number of successful balloon retrieval procedure defined as antenatal removal of the balloon.
Operative times
时间窗: Up to 34 weeks gestation
FETO placement and release operative times reported in minutes
Technical success of the balloon placement procedure
时间窗: Up to 29 weeks gestation
The number of successful balloon placement procedures defined as balloon was correctly inflated and placed/secured in the trachea.
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
Gestational Age at Delivery
时间窗: Up to 41 weeks gestation
Gestation Age reported at time of delivery
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)
次要结局
- Number of days of ventilator support(Up to 24 months post partum)
- Number of periventricular leukomalacia at < 2 months postnatally(Up to 2 months post partum)
- Use of patch or muscle flap(Up to 24 months post partum)
- Fetal Lung Growth as measured via Fetal Lung Volume(Up to 24 months post partum)
- Fetal Oxygen Dependency(Up to 24 months post partum)
- Fetal Survival(Up to 6 months post partum)
- Occurrence of severe pulmonary hypertension(Up to 24 months post partum)
- ECMO Support(Up to 24 months post partum)
- Number of days in NICU(Up to 24 months post partum)
- Number of infant complications(Up to 24 months post partum)
- Maternal hospitalization(Up to 24 months post partum)
- Route of delivery(Day 1 (post partum))
- Fetal Lung Growth as measured via LHR(Up to 24 months post partum)
研究者
Mauro H. Schenone
Regulatory Sponsor and Principal Investigator
Mayo Clinic