跳至主要内容
临床试验/NCT02083952
NCT02083952已完成不适用

Impact of Swaddle Blanket on Gastroesophageal Reflux

Valley Health System1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年2月1日最近更新:
适应症
干预措施

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

Experimental

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)

研究者

发起方
Valley Health System
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验