A Supraglottic Instillation Device for Administration of Surfactant in Neonates- A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 55
- 试验地点
- 8
- 主要终点
- Treatment failure
研究概览
简要总结
A pilot study to explore and determine feasibility and safety of the administration of surfactant through a new supraglottic device in patients from 500 to 5000 grams with RDS.
详细描述
Surfactant therapy can be life-saving for newborn infants with respiratory distress due to surfactant insufficiency, also known as respiratory distress syndrome (RDS). All commercially available surfactants for clinical use are approved for administration through an endotracheal tube. Placement of an endotracheal tube, a procedure called intubation, is stressful for the infant and associated with significant adverse effects. The proposed supraglottic instillation device allows infants to benefit from surfactant therapy while avoiding the negative effects of intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 24 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age at the time of enrollment ≥ 24 0/7 weeks
- •Weight at the time of enrollment 500- 5000 grams
- •Age ≤ 24 hours old
- •Require non-invasive respiratory support (i.e. continuous positive airway pressure, high flow nasal cannula or non-invasive ventilation)
- •Require FiO2 ≤ 40%
- •Clinical diagnosis of RDS
排除标准
- •Prior surfactant administration
- •Prior mechanical ventilation
- •Major congenital anomaly
- •Abnormality of the airway
- •Respiratory distress secondary to an etiology other than RDS (suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy)
- •Apgar score < 5 at 5 minutes of age
结局指标
主要结局
Treatment failure
时间窗: First 3 days of life
"Treatment failure" defined as requiring intubation and liquid surfactant instillation with or without mechanical ventilation.
Instillation failures
时间窗: First 10 minutes after surfactant instillation.
Instillation failure is defined as a lack of clinical response
次要结局
- Clinical response(defined as need for oxygen at 36 weeks post menstrual age)