NCT01240057已完成2 期
Randomized Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) Versus Expectant Management During Pregnancy in Fetuses With Left Sided and Isolated Congenital Diaphragma Hernia and Severe Pulmonary Hypoplasia.
University Hospital, Gasthuisberg23 个研究点 分布在 11 个国家目标入组 93 人开始时间: 2011年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 23
- 主要终点
- Survival at discharge from neonatal intensive care unit
研究概览
简要总结
This trial investigates whether prenatal intervention improves survival rate of fetuses with isolated congenital diaphragmatic hernia and severe pulmonary hypoplasia, as compared to expectant management during pregnancy, both followed by standardized postnatal care.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Patients aged 18 years or more, who are able to consent
- •Singleton pregnancy
- •Anatomically and chromosomally normal fetus
- •Left sided diaphragmatic hernia
- •Gestation at randomization prior to 29 wks plus 5 d (so that occlusion is done at the latest on 29 wks plus 6 d)
- •Estimated to have severe pulmonary hypoplasia, defined prenatally as: O/E LHR <25 %, irrespective of the liver position
- •Acceptance of randomization and the consequences for the further management during pregnancy and thereafter.
- •The patients must undertake the responsibility for either remaining close to, or at the FETO center, or being able to travel swiftly and within acceptable time interval to the FETO center until the balloon is removed.
- •Intended postnatal treatment center must subscribe to suggested guidelines for "standardized postnatal treatment".
- •Provide written consent to participate in this RCT
排除标准
- •Maternal contraindication to fetoscopic surgery or severe medical condition in pregnancy that make fetal intervention risk full
- •Technical limitations precluding fetoscopic surgery, such as severe maternal obesity, uterine fibroids or potentially others, not anticipated at the time of writing this protocol.
- •Preterm labour, cervix shortened (<15 mm at randomization) or uterine anomaly strongly predisposing to preterm labour, placenta previa
- •Patient age less than 18 years
- •Psychosocial ineligibility, precluding consent
- •Diaphragmatic hernia: right-sided or bilateral, major anomalies, isolated left-sided outside the O/E LHR limits for the inclusion criteria
- •Patient refusing randomization or to comply with return to FETO center during the time period the airways are occluded or for elective removal of the balloon
结局指标
主要结局
Survival at discharge from neonatal intensive care unit
时间窗: at discharge from neonatal intensive care unit
The baby can be discharged either alive (and then it qualifies as "surviving at discharge") or dead. Not discharged babies have not reached the primary endpoint.
次要结局
- presence of neonatal sepsis, intraventricular haemorrhage, retinopathy grade III or higher(within hospital stay)
- presence of periventricular leucomalacia(2 months of life)
- occurrence of pulmonary hypertension(within first weeks of life)
- number of days till full enteral feeding(within first 2 years of life)
- presence of gastro-esophagal reflux(at discharge)
- prenatal increase in lung volume after FETO(prior to balloon removal)
- grading of oxygen dependency(born >32 wks: between 28-56d of life; born <32wks: 36wks postmenstrual age)
- number of days in Neonatal Intensive Care Unit (NICU)(within hospital stay)
- number of days of ventilatory support(within NICU stay)
- requirement for use of patch for repair(at the time of postnatal surgery)
- Need for Extracorporeal membrane oxygenation(during NICU admission)
- Defect size(at the time of postnatal surgery)
- number of days alive in case of postnatal death(during NICU admission)
- day of surgery(within hospital stay)
- bronchopulmonary dysplasia(with the first 8 weeks)
研究者
Jan Deprest
MD, PhD
University Hospital, Gasthuisberg
研究点 (23)
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