跳至主要内容
临床试验/NCT02902055
NCT02902055终止4 期

Life-threatening Acute Respiratory Failure in Children: to Breathe or Not to Breathe Spontaneously, That's the Question

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2019年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
3
试验地点
1
主要终点
the cumulative respiratory morbidity score 12 months after PICU discharge, adjusted for confounding by age, gestational age, family history of asthma and/or allergy, season in which questionnaire was filled out and parental smoking

研究概览

简要总结

Paediatric acute respiratory distress syndrome (ARDS) is a manifestation of severe, life-threatening lung injury. Care for paediatric patient is mainly supportive and based on what works in adults and personal experiences, including the use of mechanical ventilation. However, differences in lung physiology and immunology between (young) children and adults suggests that adaptation of adult practices into paediatrics may not be justified. A study in adults with severe ARDS showed that early use of neuromuscular blocking agents (NMBA) improved 90-day survival and increased time off the ventilator without increasing muscle weakness. It is unknown if this is also true for paediatric ARDS

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
0 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Rocuronium 1 mg/kg i.v.

Active Comparator

Neuromuscular blocking agent

干预措施: Neuromuscular Blocking Agents (Drug)

Isotonic saline

Active Comparator

干预措施: Isotonic saline (Drug)

结局指标

主要结局

the cumulative respiratory morbidity score 12 months after PICU discharge, adjusted for confounding by age, gestational age, family history of asthma and/or allergy, season in which questionnaire was filled out and parental smoking

时间窗: 12 months after PICU discharge

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Kneyber

Chief, division of paediatric critical care medicine / Project leader

University Medical Center Groningen

研究点 (1)

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