North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of successful placement of FETO device
研究概览
简要总结
This registry study aims to confirm that FETO increases neonatal survival to discharge and reduces long-term morbidity in fetuses with isolated left CDH and o/e LHR < 30%, or isolated right CDH and o/e LHR ≤ 45%, compared to those receiving standard care. This prospective registry plans to enroll 80 pregnant women (40 treatment/40 control) with fetuses diagnosed with isolated CDH, and the children will be followed for up to 24 months.
详细描述
The purpose of this study is to evaluate successful placement and removal of Fetoscopic Endoluminal Tracheal Occlusion (FETO) device in cases of intrathoracic liver herniation with isolated left congenital diaphragmatic hernia (LCDH) with Observed/Expected (O/E) Lung to Head Circumference Ratio (LHR) < 30% or isolated right congenital diaphragmatic hernia (RCDH) with O/E LHR ≤ 45%,to compare survival to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation and isolated LCDH with O/E LHR < 30% that receive FETO procedure performed at 27 weeks + 0 days to 29weeks + 6 days of gestation to those with intrathoracic liver herniation, isolated LCDH and o/e LRH < 30% that undergo expectant management, to compare the neonatal survival rate to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation, isolated RCHD with o/e LHR ≤ 45% that undergo FETO procedure performed at 27 weeks + 0 days to 29 weeks + 6 days gestation to those with intrathoracic liver herniation, isolated RCHD and o/e LHR ≤ 45% that elect to proceed with expectant management, to evaluate the frequency of maternal and fetal complications associated with FETO procedure, to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated LCDH survivors with o/e LHR <30% when compared to isolated LCDH with o/e LRH <30% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation and to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated RCDH survivors with o/e LHR ≤ 45% when compared to isolated RCHD with LHR ≤ 45% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women age 18 years and older
- •Singleton pregnancy
- •Normal Karyotype, chromosomal microanalysis (CMA) with non-pathologic variants, whole exome sequencing (WES) or whole genome sequencing (WGS). Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks gestation.
- •Gestational age at enrollment is prior to 29 weeks + 6 days gestation.
- •Intrathoracic liver herniation:
- •Isolated left CDH with o/e LHR < 30% at enrollment (18wks + 0 days to 29wks + 5 days gestation).
- •Isolated right CDH with o/e LHR ≤ 45% at enrollment (18wks + 0 days to 29wks + 5 days gestation).
- •Cervical length by transvaginal ultrasound ≥ 20 mm within 24 hours prior to FETO procedure.
- •Patient meets psychosocial criteria.
- •Informed consent understood.
排除标准
- •Patient < 18 years of age
- •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, placenta previa.
- •Psychosocial ineligibility, precluding consent:
- •Inability to reside within 30 minutes of Johns Hopkins Hospital Center for Fetal Therapy.
- •The 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 Johns Hopkins Hospital Center for Fetal Therapy.
- •Bilateral CDH, isolated left sided CDH with O/E LHR ≥ 30% (18wks + 0 days to 29wks + 5 days gestation), isolated right sided CDH with O/E LHR > 45% (18wks + 0 days to 29wks + 5 days gestation), as determined by ultrasound.
- •No liver herniation into thoracic cavity.
- •Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. Exclude chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., CDH and congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns).
- •Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy.
- •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 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 anomalies such as large or multiple fibroids or Mullerian duct abnormality.
- •There is 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.
研究组 & 干预措施
Fetal Treatment Arm (FETO Group)
干预措施: Fetal Treatment Arm (FETO Group) (Device)
Expectant Management Arm (Control Group)
Standard of care treatment for babies with congenital diaphragmatic hernia.
结局指标
主要结局
Number of successful placement of FETO device
时间窗: 10-60 minutes after surgery begins
Number of successful removal of FETO device
时间窗: Immediately after the procedure (about 1 hour after start of surgery)
Number of FETO procedure complications
时间窗: End of study (24 months)
Complications include: Failure FETO insertion procedure, FETO device dislodgement potentially requiring a second FETO insertion, Fetal intraoperative injury, Procedural hemorrhage, Bleeding from insertion site or Abruptions, Post-procedural hemorrhage PPROM, Preterm delivery, Chorioamnion separation, Chorioamnionitis, Polyhydramnios, Oligohydramnios, Emergent removal due to obstetrical complication, Failed percutaneous or fetoscopic removal requiring cesarean section or exit procedure for removal, Neonatal death due to asphyxia if delivery before FETO removal, and Non-reassuring fetal heart rate monitoring.
Number of neonates that survived
时间窗: From delivery to hospital discharge
Neonatal survival to discharge
次要结局
- Number of infants that survived(24 months)
- Number of infants that show presence of pulmonary hypertension(24 months)
- Number of infants that show need for supplemental oxygen(24 months)
- Number of infants that show periventricular leukomalacia(At less than 2 months postnatally)
- Number of Infants that develop sepsis(24 months)
- Number of infants that develop Intraventricular hemorrhage (grade 0-III)(24 months)
- Number of infants that develop retinopathy of prematurity (grade 3 or higher)(24 months)
- Number of infants that develop gastro-esophageal reflux(24 months)
- Number of infant hospital readmissions(End of study (24 months))
- Cause of infant hospital readmissions(End of study (24 months))
- Number of infants that show childhood growth failure(24 months)
- Number of infants that show recurrence of CDH repair(24 months)
- Number of infants that develop bowel obstruction(24 months)
- Number of infants that show neurodevelopmental delay as assessed by the Bayley Scales of Infant and Toddler Development-III(BSID)(24 months)
- Number of infants that develop bronchopulmonary dysplasia(24 months)
- Number of infants that show presence of pulmonary hypertension(6 months)
- Number of infants that show need for supplemental oxygen(12 months)
- Number of infants that show need for supplemental oxygen(18 months)
- Number of infants that show presence of pulmonary hypertension(12 months)
- Number of Infants that develop sepsis(6 months)
- Number of infants that show presence of pulmonary hypertension(18 months)
- Number of infants that show need for supplemental oxygen(6 months)
- Number of infants that survived(12 months)
- Number of infants that survived(18 months)
- Number of infants that survived(6 months)
- Number of Infants that develop sepsis(12 months)
- Number of Infants that develop sepsis(18 months)
- Number of infants that develop Intraventricular hemorrhage (grade 0-III)(6 months)
- Number of infants that develop Intraventricular hemorrhage (grade 0-III)(12 months)
- Number of infants that develop Intraventricular hemorrhage (grade 0-III)(18 months)
- Number of infants that develop retinopathy of prematurity (grade 3 or higher)(6 months)
- Number of infants that develop retinopathy of prematurity (grade 3 or higher)(12 months)
- Number of infants that develop retinopathy of prematurity (grade 3 or higher)(18 months)
- Number of infants that develop gastro-esophageal reflux(6 months)
- Number of infants that develop gastro-esophageal reflux(12 months)
- Number of infants that develop gastro-esophageal reflux(18 months)
- Number of infants that show childhood growth failure(6 months)
- Number of infants that show childhood growth failure(12 months)
- Number of infants that show childhood growth failure(18 months)
- Number of infants that show recurrence of CDH repair(6 months)
- Number of infants that show recurrence of CDH repair(12 months)
- Number of infants that show recurrence of CDH repair(18 months)
- Number of infants that develop bowel obstruction(6 months)
- Number of infants that develop bowel obstruction(12 months)
- Number of infants that develop bowel obstruction(18 months)
- Number of infants that develop bronchopulmonary dysplasia(6 months)
- Number of infants that develop bronchopulmonary dysplasia(12 months)
- Number of infants that develop bronchopulmonary dysplasia(18 months)