Curosurf/Budesonide for Infants With Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- need of pulmonary surfactant
研究概览
简要总结
Infants showing high local pulmonary inflammation diagnosted by respiratory distress syndrome usually need the second or more pulmonary surfactant and is easier to developing to Brochopulmonary. Cursurf is used worldwide in infants with respiratory distress syndrome, Budesonide is a glucocorticoid with a high local anti-inflammatory effect.Our hypothesis is Cursurf combined with Budesonide could reduced the need of Cursurf and incidence of Brochopulmonary dysplasia.
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
- — 至 12 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of respiratory distress syndrome
排除标准
- •pneumothorax
- •surgical disease
- •major congenical defects
研究组 & 干预措施
Cursurf and Budesonide
The baby with respiratory distress syndrome was given Cursurf and Budesonide through intubation.
干预措施: Budesonide (Drug)
结局指标
主要结局
need of pulmonary surfactant
时间窗: one month
The hypothesis is Cursurf/Budesonide could reduced the need of pulmonary surfactant
次要结局
- the incidence of bronchopulmonary dysplasia(gestional age 36 weeks or later)
研究者
Chen Long,MD
MD
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University