NCT06179472进行中（未招募）不适用
Infant Survival and Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial
Inna Lobeck2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年4月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Use of Extracorporeal Membrane Oxygenation (ECMO) support
研究概览
简要总结
The purpose of the study is to determine the infant survival and long-term effects of performing Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery and removal of the BALT Goldbal2 balloon at Children's Mercy Hospital. We hypothesize that FETO balloon placement may increase survival and decrease morbidity when compared to standard prenatal care for the treatment of severe left or right congenital diaphragmatic hernia (CDH).
详细描述
FETO is an un-blinded non-randomized two arm feasibility and efficacy study being conducted at Children's Mercy Hospital.
Potential subjects will be identified from the patient's standard of care prenatal evaluation for CDH at Children's Mercy Hospital, which includes the following:
- Comprehensive obstetrical ultrasound examination including documentation of cervical length, gestational age, biometry, liver herniation, hepatic vasculature, sonographic lung volume, amniotic fluid level, membrane status, and lung-to-head circumference ratio (LHR) calculation.
- Fetal echocardiography to evaluate for structural cardiac anomalies
- Fetal Magnetic resonance imaging (MRI) 24 - 26 weeks gestation to confirm fetal liver herniation, calculate total fetal lung volume (TFLV) and Observed/Expected total fetal lung volume (O/E TFLV).
- Maternal history including demographics, physical examination, vital signs, height and weight
- Laboratory tests, including microarray and karyotype via amniocentesis
- Review of concomitant medications
- Psychosocial evaluation with a social worker and/or health psychologist.
Eligibility Review and Informed Consent Process
The Principal Investigator and member of the study team will review the informed consent document with eligible patients. This includes the following:
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
- •Pregnant persons age 18 years and older
- •Singleton pregnancy
- •Absence of life-limiting genetic anomalies on microarray or karyotype on amniocentesis. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks gestation
- •Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects (small ventricular septal defect (VSD)/atrial septal defect (ASD) may be included as they will not alter outcome and are not life-limiting)
- •Left or Right CDH with liver up without presence of concomitant life-limiting anomalies.
- •Gestational age for Left-CDH at enrollment prior to 29 weeks plus 6 days for O/E LHR <30%; for Right-CDH with O/E LHR <45% gestational age at enrollment prior to 29 weeks plus 6 days.
- •Meets psychosocial criteria
- •Willing to reside within 30 minutes of Children's Mercy Hospital Fetal Health Center and ability to maintain follow up appointments
- •Patient has a support person (e.g. spouse, partner, friend, or parent) that is available to stay with her for the duration of the pregnancy.
- •Willing to comply with restrictions of daily living including inability to exercise, have intercourse or return to work.
排除标准
- •Pregnant persons < 18 years of age
- •Multi-fetal pregnancy
- •Rubber latex allergy
- •History of preterm labor, cervix shortened (<15mm 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 Children's Mercy Hospital Fetal Health Center until balloon removal or delivery (if clinically indicated)
- •Patient does not have a support person (e.g., spouse, partner, parent) available to stay with the patient until balloon removal or duration of the pregnancy (if clinically indicated)
- •Adult unable to consent
- •Prisoners
- •Social work or health psychology will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude the patient as a potential candidate.
- •Bilateral CDH, isolated left-sided with O/E LHR ≥30% (measured at 18 weeks 0 days to 29 weeks 5 days) as determined by ultrasound, isolated right-sided CDH with O/E LHR ≥45% (measured at 18 years 0 days to 29 weeks 5 days) as determined by ultrasound.
- •Additional life-limiting fetal anomaly by ultrasound, MRI or echocardiogram that may affect outcome. These include chromosomal or anatomic abnormalities, associated anomalies recognized to alter survival prognosis (i.e., CDH and severe congenital heart disease) or presence of an underlying genetic syndrome (e.g., Fryns). No cases will be removed post hoc if abnormalities are discovered in the course of post-operative monitoring.
- •Patient contraindication to fetoscopic surgery or severe medical condition in pregnancy
- •History of incompetent cervix with or without cerclage
- •Placental abnormalities (previa, abruption, accreta) known at the time of enrollment
- •Pregnant person-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
- •Pregnant person tests positive for HIV, Hepatitis-B, Hepatitis-C. Due to of the increased risk of transmission to the fetus during maternal-fetal surgery the patient must test negative for these conditions prior to 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.
- •Patient refusal to receive blood products
- •Additional major anomaly or abnormality that would prevent successful FETO, per discretion of the Principal Investigator
结局指标
主要结局
Use of Extracorporeal Membrane Oxygenation (ECMO) support
时间窗: Birth to 6 months
Number of infants requiring ECMO support
Infant survival
时间窗: Birth to 24 months
Infant survival will be measured from delivery to discharge, at 6, 12, and 24 months of age.
Number of occurrences and severity of pulmonary hypertension
时间窗: Birth to 6 months
Recording the occurrence of severe pulmonary hypertension based on echocardiogram
次要结局
- Change in fetal lung growth(The first ultrasound within 1 week after balloon removal (balloon removal ideally at 34 weeks gestation))
- Maternal Complications(Up to 4-6 weeks post-partum)
- Gestational age at delivery(At the time of delivery)
- Number of infants requiring supplemental oxygen(Birth to 24 months)
- Number of days in neonatal intensive care unit (NICU) / pediatric intensive care unit (PICU)(Birth to 1 year)
研究者
Inna Lobeck
Physician
Children's Mercy Hospital Kansas City
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090Retinopathy of Prematurity (ROP)NCT04015180Bayer100
已完成
3 期
Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment StudiesObstetric Labour, PrematureNCT02292784GlaxoSmithKline98
终止
4 期
Acute and Long-Term Outcome Investigations of Fenofibrate on Severely Burned PatientsSecond or Third Degree BurnsNCT01574131The University of Texas Medical Branch, Galveston3
已完成
2 期
Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)Retinopathy of Prematurity (ROP)NCT02386839Shire76
已完成
2 期
18 Month Follow Up of Preterm Infants Enrolled in the Cord Clamping StudyDevelopmental DelayNCT01426698University of Rhode Island208