A Pilot Study to Evaluate the Use of the Neotech RAM Nasal Cannula for CPAP and Bi-PAP Application in Infants 28-42 Weeks Gestation in a Neonatal Intensive Care Unit (NICU)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- NCPAP
研究概览
简要总结
This study will explore the RAM Nasal Cannula as a means of providing CPAP and Bi-PAP to infants 28-42 weeks gestation to prevent nasal septal erosion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 28 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with birth weight < 1500 grams AND/OR <32 weeks gestational age
- •Infants between 34-42 weeks gestational age and exclusive breastfeeding with no risk of nasal septal erosion OR Infants between 28-42 weeks gestational age at risk of nasal septal erosion
排除标准
- •Infants with major congenital and upper airway anomalies
- •Infants requiring ETT (endotracheal tube) mechanical ventilation
- •Infants receiving no respiratory support
研究组 & 干预措施
RAM Cannula
干预措施: RAM Nasal Cannula (Other)
结局指标
主要结局
NCPAP
时间窗: 5 days
The study will determine if the RAM Nasal Cannula is providing adequate CPAP to neonates. This will be measured with the Braden Q score. The Braden Q Scale is composed of seven subscales. All seven subscales are rated from 1 (least favorable)to4(most favorable); patients receive only one score per subscale.
Bi-PAP
时间窗: 5 days
The study will determine if the RAM Nasal Cannula is providing adequate Bi-PAP to neonates. This will be measured with the Braden Q score every 3 hours. The Braden Q Scale is composed of seven subscales. All seven subscales are rated from 1 (least favorable)to4(most favorable); patients receive only one score per subscale.
次要结局
- High Flow Humidity(5 days)