A Multicenter, Randomized, Masked, Placebo-Controlled Trial to Assess the Safety and Efficacy of Lucinactant in Acute Hypoxemic Respiratory Failure in Children Up to Two Years of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 3
- 主要终点
- Duration of Mechanical Ventilation Through 14 Days
研究概览
简要总结
Treatment with lucinactant, a peptide-containing synthetic lung surfactant, will be evaluated in young children with acute respiratory failure who require mechanical ventilation (life support), to determine if it is safe and if treatment with lucinactant will reduce the number of days a child needs mechanical ventilation (life support).
详细描述
Determine the safety and tolerability of administration of a peptide-containing synthetic lung surfactant, lucinactant, in children up to two years of age and assess whether treatment with lucinactant can decrease the duration of mechanical ventilation in young children.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 38 weeks (corrected age) to 2 years (24 months)
- •Intubated and mechanically ventilated (MV) for ≥ 6 hours and anticipated need for MV for ≥ 24 hours
- •Persistent hypoxia
- •Written informed consent
排除标准
- •Mechanical Ventilation for > 48 hours
- •Oxygenation index ≥ 25, if arterial line was avialable
- •Pre-existing clinically significant or palliated/uncorrected cardiac disease adversely affecting cardiopulmonary function and gas exchange
- •Neuromuscular disease or hypotonia
- •Upper airway disease
- •Baseline requirment for supplemental oxygen
- •Untreated pneumothorax
- •Off-label use of commercially available surfactant outside neonatal period
- •History of prematurity and passive immunoprophylaxis with humanized monoclonal antibody
- •Head injury with Glasgow Coma Scale < 8
- •Brain death or impending brain death
- •Do not resuscitate orders
- •Cardiopulmonary resuscitation within 6 hours of meeting entry criteria
- •Experimental therapy in which the intervention potentially affects respiratory outcomes
- •Any transplant recipient
- •Meconium aspiration syndrome
- •Bordetella pertussis infection confirmed via laboratory tests and/or highly suspected pertussis infection
研究组 & 干预措施
Lucinactant
SURFAXIN® (lucinactant) for intratracheal instillation
干预措施: Lucinactant (Drug)
Sham Air
Sham air (placebo) instillation
干预措施: Sham Comparator (Other)
结局指标
主要结局
Duration of Mechanical Ventilation Through 14 Days
时间窗: Up to 14 Days
Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days.
次要结局
- Ventilator-free Days; Duration of Days on Oxygen, Intensive Care Unit (ICU) Stay, and Hospitalization Through 14 Days(Up to 14 days)