Efficacy and Safety of Exosurf Neonatal and Survanta for the Treatment of Respiratory Distress Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 617
- 试验地点
- 13
- 主要终点
- Death or bronchopulmonary dysplasia
研究概览
简要总结
The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome.
详细描述
The NICHD Neonatal Research Network conducted a randomized trial at 11 centers comparing the efficacy of two surfactants -- Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories) -- for the treatment of neonatal respiratory distress syndrome. Newborn infants with birth weights of 501-1500g with respiratory distress syndrome who were receiving assisted ventilation with 30% oxygen or more within 6 hours of birth were enrolled between January 1991 and January 1992. Infants were randomly assigned to receive up to four intratracheal doses of either Exosurf Neonatal or Survanta.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn infants weighing 501 to 1500 gm with respiratory distress syndrome were receiving assisted ventilation with 30% oxygen or more
排除标准
- •Less than 6 hours of age
研究组 & 干预措施
Surfactant 1
Exosurf Neonatal (Burroughs Wellcome Co.)
干预措施: Exosurf (Drug)
Surfactant 2
Survanta (Ross Laboratories)
干预措施: Survanta (Drug)
结局指标
主要结局
Death or bronchopulmonary dysplasia
时间窗: 28 days of life
次要结局
- Average fraction of inspired oxygen (FIO2)(72 hours after treatment)
- Mean airway pressure (MAP)(72 hours after treatment)