Early Surfactant Followed by Nasal CPAP to Reduce the Use of Mechanical Ventilation Without Additional Morbidity in Infants 1250- 2000 Grams With RDS
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 61
- 试验地点
- 13
- 主要终点
- Need for mechanical ventilation following randomization
研究概览
简要总结
Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.
详细描述
Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. The role of surfactant therapy in the management of larger infants with respiratory distress syndrome (RDS) was unclear. In many neonatal intensive care units, these infants were routinely managed with continuous positive airway pressure (CPAP) alone.
This trial tested whether early use of surfactant combined with CPAP would ameliorate the course of RDS without an increased risk of death. Primary study outcomes were measures of use of mechanical ventilation, and thereby likely reduction in risk of ventilator-associated morbidity.
Eligible infants were randomized before the infant is 12 hours of age to receive either: early surfactant followed by extubation within 30 minutes and application of CPAP (intervention group); or surfactant according to current center practice, only after initiation of mechanical ventilation (control group).
The trial was stopped after 7 months for lack of recruitment.
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
- None
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
- •Infants born at 1,250-2g000 grams birth weight
- •<12 hours of age
- •Clinical and radiographic diagnosis of respiratory distress syndrome (RDS)
- •Receiving supplemental oxygen with head-hood Fi02 of 0.35 to 0.50 or CPAP Fi02 of 0.25 to 0.50 to maintain oxygen saturation less than 90 percent and more than 96 percent
排除标准
- •Receiving mechanical ventilation
- •Pulmonary hemorrhage
- •Major congenital anomaly
- •Congenital non-bacterial infection
- •Parental refusal of consent
- •Refusal of attending neonatologist
研究组 & 干预措施
Early surfactant group
干预措施: Early surfactant (Drug)
Standard Practice group
干预措施: Standard practice (Drug)
结局指标
主要结局
Need for mechanical ventilation following randomization
时间窗: Until hospital discharge or 120 days of life
次要结局
- Mean duration of mechanical ventilation(Until hospital discharge or 120 days of life)
- Risk morbidities associated with mechanical ventilation and/or early surfactant administration(Until hospital discharge or 120 days of life)