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临床试验/EUCTR2018-001169-18-GB
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

发起方
niversity Of Liverpool

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