EUCTR2018-001169-18-GB进行中(未招募)1 期
The efficacy and mechanism of surfactant therapy for critically ill infants with bronchiolitis: The Bronchiolitis Endotracheal Surfactant Study. - The Bronchiolitis Endotracheal Surfactant Study (BESS)
niversity Of Liverpool0 个研究点目标入组 284 人开始时间: 2018年8月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 284
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Term-born infants < 26 weeks old and preterm-born infants < 26 weeks corrected age†
- •2.Diagnosis of bronchiolitis (see below)
- •3.Requires conventional invasive MV via tracheal intubation
- •4. Parent or person with parental responsibility has given written informed consent for trial participation
- •†Premature born infants have their age corrected to account for weeks of lost gestation
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Major congenital anomalies, including complex or haemodynamically compromising cardiac anomalies.
- •2.Congenital neuromuscular disease
- •3.Already intubated for MV for >48 hours or likely to have been intubated for MV for >48 hours by randomisation
- •4.Have received or are receiving extracorporeal membrane oxygenation (ECMO) or oscillation during this episode of bronchiolitis
- •5.Have received or are receiving intratracheal administration of any surfactant during this episode of bronchiolitis
- •6.Receiving MV for primary apnoea rather than respiratory failure
- •7.A decision to wean to extubation has already been made
- •8.Clinical judgement of futility
研究者
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