Advancement of Modified Bubble CPAP for the Use in Children in Low Resource Settings: A Study of Safety
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- determine if a modified bCPAP device with an adapted nasal cannula can be used safely in children outside of the neonatal period
研究概览
简要总结
This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to fit older children, will create a safe form of respiratory support that may help to decrease respiratory distress and thus mortality from pneumonia.
详细描述
This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to fit older children, will create a safe form of respiratory support that may help to decrease respiratory distress and thus mortality from pneumonia. Children age 1 month (mo) to 5 years (y) admitted to Gulu Regional Referral Hospital in Gulu, Uganda with respiratory distress will be evaluated for use of the modified bCPAP device as treatment for their respiratory distress (in addition to their routine care, i.e. antibiotics, nutrition support)
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
- 1 Month 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1mo-5y Hypoxia and/or respiratory distress Hypoxia- Oxygen saturation <92% despite 2LPM nasal cannula support Modified TAL's Respiratory Score >3
排除标准
- •Pneumothorax
- •Congenital lung disease
- •Cyanotic heart disease
- •Nasal trauma/facial injury/congenital anomaly (cleft) that makes bubble CPAP nasal interface unusable
- •Nasal tissue injury
- •Active nosebleed
- •Recent abdominal surgery or significant abdominal distension
- •Agonal respirations
- •Imminent death within the next 1-2hou
研究组 & 干预措施
Bubble CPAP
Bubble CPAP for 28 days
干预措施: Bubble CPAP (Device)
结局指标
主要结局
determine if a modified bCPAP device with an adapted nasal cannula can be used safely in children outside of the neonatal period
时间窗: 28 days
A composite of potential adverse events that could be attributable to bCPAP use. Adverse events such as nasal erosion, nosebleed, and aerophagia will be graded on a scale
次要结局
- show decreased mortality in patients treated with a modified bCPAP respiratory support device.(28 days)