NCT07564297Enrolling By Invitation不适用
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of FETO procedure complications
研究概览
简要总结
The purpose of this research is to determine if babies who undergo a Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure survive more often and have less long-term complications than babies who have similarly severe Congenital Diaphragmatic Hernia (CDH) that have not had the FETO procedure performed during pregnancy
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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, CMA with non-pathological variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
- •Gestational age at enrollment prior to 29 6/7 weeks
- •Intrathoracic liver herniation Isolated left CDH with O/E LHR < 30% at enrollment (18 0/7 to 29 5/7 weeks.) Isolated right CDH with O/E LHR < 45% at enrollment (18 0/7 to 29 5/7 weeks).
- •Cervical length by transvaginal ultrasound > 20 mm within 24 to 48 hours prior to FETO procedure
- •Patient meets psychosocial criteria
- •Informed consent understood
排除标准
- •Multi-fetal pregnancy
- •History of natural rubber latex allergy
- •Preterm labor, cervix shortened (<20 mm at enrollment or within 24 to 48 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 Mayo Clinic. 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.
- •Bilateral CDH, isolated left sided CDH with O/E LHR 30% (measured at 180 to 295 weeks), isolated right sided CDH with O/E LHR > 45% (measured at 180 to 295 weeks), as determined by ultrasound.
- •No intrathoracic liver herniation
- •Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns) by ultrasound, MRI, or echocardiogram at the fetal treatment center.
- •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 anomaly 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
Standard of Care
干预措施: Standard of Care (Other)
FETO Surgery
干预措施: Fetoscopic Endoluminal Tracheal Occlusion (Device)
结局指标
主要结局
Number of FETO procedure complications
时间窗: 2 years
FETO procedure complications are defined as device dislodgement, intraoperative injury to fetus, procedural hemorrhage, post-procedural hemorrhage, preterm delivery, chorioamnion separation, chorioamnionitis, polyhydramnios, oligohydramnios, failed percutaneous or fetoscopic removal requiring cesarean section or EXIT procedure for removal, neonatal death due to asphyxia (if delivery before FETO removal), non-reassuring fetal heart rate monitoring.
Neonatal survival to discharge
时间窗: 2 years
Number of neonates to survive from delivery to hospital discharge
次要结局
- Need for supplemental oxygen(6, 12, 18, and 24 months of age)
- Periventricular leukomalacia at < 2 months postnatally(2 months)
- Intraventricular hemorrhage (grade 0-III)(6, 12, 18, and 24 months of age)
- Retinopathy of prematurity (grade 3 or higher)(6, 12, 18, and 24 months of age)
- Gastro-esophageal reflux(6, 12, 18, and 24 months of age)
- Number of infant hospital readmissions(6, 12, 18, and 24 months of age)
- Childhood growth failure(6, 12, 18, and 24 months of age)
- Recurrence of Congenital Diaphragmatic Hernia (CDH) repair(6, 12, 18, and 24 months of age)
- Bowel obstruction(6, 12, 18, and 24 months of age)
- Neurodevelopmental delay(6, 12, 18, and 24 months of age)
- Bronchopulmonary dysplasia(6, 12, 18, and 24 months of age)
- Presence of pulmonary hypertension(6, 12, 18, and 24 months of age)
研究者
Mauro H. Schenone
Principal Investigator
Mayo Clinic
研究点 (1)
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