The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Respiratory Morbidity
研究概览
简要总结
Sustained inflation (SI) has been reported to be effective for reducing the need for intubation and/or invasive ventilation in preterm infants. However, it has also an important role to support the initial breaths and liquid removal from the airways. Therefore, the investigators hypothesized that SI performed just after birth may help to facilitate the transitional period and decrease the incidence of early respiratory morbidities such as transient tachypnea in term infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 2 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •term newborns
- •parental informed consent
- •inborn infants
排除标准
- •major congenital/chromosomal abnormalities
- •lack of informed consent
- •outborn infants
- •Premature infants
研究组 & 干预措施
Sustained Inflation Group
Includes the infants who administered sustained inflation for 5 seconds with a pressure of 30cm H20 immediately after the delivery.
干预措施: Sustained Inflation (Other)
No Intervention group
Includes routine neonatal care in the delivery room
结局指标
主要结局
Respiratory Morbidity
时间窗: 2 hours
RDS, TTN, requirement for supplemental oxygen, intubation or mechanical ventilation support
次要结局
未报告次要终点
研究者
Merih Cetinkaya
Associate Professor, MD,PhD
Kanuni Sultan Suleyman Training and Research Hospital