NCT03748173终止1 期
Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04 A Pilot Study of Aerosol Surfactant for Bronchiolitis in Infants
ONY2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2019年1月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Improvement in Respiratory Status
研究概览
简要总结
Delivery of aerosolized Infasurf to bronchiolitis patients with who are not on assisted ventilation can provide sufficient delivery of Infasurf to small airways to improve ventilation and thereby shorten the duration of the respiratory illness.
详细描述
This pilot clinical trial will compare "usual care" to aerosolized Infasurf. The study objective is to determine
- Do bronchiolitis patients tolerate aerosolized Infasurf?
- Does aerosolized Infasurf induce an improvement in respiration?
- If it does how large a dose is required to observe a positive effect?
- Is the positive effect transient, if so what is the range of duration of the effect?
- Does retreatment also result and a positive response?
- Does aerosolized Infasurf result in more rapid sustained improvement? is superior to.
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
- 0 Months 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant ≤ 4 months of age admitted to the PICU with the clinical diagnosis of bronchiolitis
- •Severe illness as reflected by a bronchiolitis score ≥ 4 and requiring high flow nasal cannula or continuous positive airway pressure for respiratory support
- •Within 4 hours of PICU admission.
排除标准
- •Need for non-invasive BiPAP or invasive ventilation
- •Significant Co-morbidities
- •Chronic lung disease (evidenced by supplemental oxygen, home ventilation, or chronic diuretic therapy for CLD)
- •Unrepaired congenital heart disease
- •Immune compromise
- •Neuromuscular weakness
- •Tracheostomy
- •Influenza as the etiologic agent of bronchiolitis
- •Inability to stabilize the infant to a bronchiolitis score < 8
结局指标
主要结局
Improvement in Respiratory Status
时间窗: 24 hours post PICU admission
Incidence of positive respiratory response to Infasurf® Aerosol defined as Bronchiolitis Clinical Score decreased by 2 points or to ≤4.
次要结局
- Need of Respiratory support(24 hours post PICU admission)
研究者
研究点 (2)
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