Impact of Swaddle Blanket on Gastroesophageal Reflux
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- pH
研究概览
简要总结
Gastroesophageal reflux disease (GERD) has been reported in up to 85% of all infants born prematurely, and has been associated with a wide range of symptoms. These include irritability, pauses in breathing, heart rate drops, declines in oxygen levels, chronic lung disease, and delays in growth and development. A novel approach to the mangement of GERD in infants is the use of an abdominal band, applying gentle pressure and possibly reducing the reflux of acid from the stomach. The purpose of this study is to evaluate the impact of a swaddle blanket with an abdominal band insert on the incidence of infant apnea, bradycardia, oxygen declines, and pH (acid) changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Days 至 180 Days(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- NICU patients who have a 5 channel study requested by the attending neonatologist -
排除标准
- 未提供
研究组 & 干预措施
swaddle blanket
干预措施: Swaddle Blanket (Other)
结局指标
主要结局
pH
时间窗: 24 hours
all epochs of pH values below 4.0 will be measured
次要结局
- apnea(24 hours)
