NCT02016651已完成不适用
Positioning and Gastric Aspiration in Ventilated Premature Infants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Pepsin concentration in tracheal aspirate
研究概览
简要总结
Gastro-esophageal reflux and aspiration is a common problem in premature infants receiving mechanical ventilation. Pepsin measured in tracheal aspirate (TA) emerged as a specific marker for aspiration. The objective of this study is to examine if TA pepsin will change when ventilated premature infants are positioned in two different positions; on their back vs. on their right side.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born between 28 and 32 weeks gestational age
- •postnatal age > 72 hours
- •tracheally intubated and receiving conventional mechanical ventilation
- •feeding enterally more than 20 ml per day.
排除标准
- •neurological insult in the form of perinatal asphyxia (pH <7, base deficit more than 12, Apgar score at < 3 at 5 minutes of life), intracranial hemorrhage grades 3 or 4 at 72 hours of age or periventricular leucomalacia
- •major congenital anomalies, or gastrointestinal anomalies such as tracheoesophageal fistula, or necrotizing enterocolitis ,
- •receiving xanthine derivatives, H2 blockers, prokinetics, proton pump inhibitors or sedation
结局指标
主要结局
Pepsin concentration in tracheal aspirate
时间窗: 6 hours after intervention
次要结局
未报告次要终点
研究者
Hany Aly
Visiting Professor of Pediatrics
Cairo University
研究点 (2)
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