Premature Enhanced Automated Capture of Comfort Knowledge (PEACOCK)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Physiologic Signal Before Procedure: Heart Rate
研究概览
简要总结
The goal of this observational study is to develop methods that could provide continual monitoring of comfort levels for preterm neonates in hospitals.
详细描述
As preterm neonates have not developed ways to communicate how they are feeling like children or adults do, clinicians must rely on their own understanding and professional judgements to decide how comfortable they are. It is known that preterm neonates can display emotion through ways such as facial expressions, body movements and changes in their physiology such as heart rate. The investigators will record both behavioural (audiovisual) and physiologic (heart rate, blood oxygen saturation) signals during routine clinical procedures ranging from comforting, through discomforting to painful that are necessary as part of high-quality medical care.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm Infants born <36 completed weeks of gestation
- •Medically stable
- •Written informed consent from parents
排除标准
- •Infants with significant brain, spine, or congenital abnormality
- •Parents unwilling to provide consent
- •Infants with postmenstrual age >36 weeks
结局指标
主要结局
Physiologic Signal Before Procedure: Heart Rate
时间窗: 1 minute starting before procedure
Heart rate captured by bedside ECG monitor
Audiovisual signal Before Procedure
时间窗: 1 minute starting before procedure
Bedside recording using camera and microphone.
Audiovisual Signal During Procedure
时间窗: 1 minute during procedure
Bedside recording using camera and microphone
Pain Score Before Procedure
时间窗: 1 minute recording before procedure
Score provided by nurses from Neonatal Pain, Agitation \& Sedation Scale. Pain/Agitation scores range from 0-13, higher scores indicate higher pain/agitation levels.
Pain Score After Procedure
时间窗: 1 minute recording immediately after procedure
Score provided by nurses from Neonatal Pain, Agitation \& Sedation Scale. Pain/Agitation scores range from 0-13, higher scores indicate higher pain/agitation levels.
Physiologic Signal After Procedure: Blood Oxygen Saturation
时间窗: 1 minute immediately after procedure
Blood oxygen saturation captured by bedside oximetry monitor
Physiologic Signal Before Procedure: Blood Oxygen Saturation
时间窗: 1 minute starting before procedure
Blood oxygen saturation captured by bedside oximetry monitor
Physiologic Signal During Procedure: Heart Rate
时间窗: 1 minute during procedure
Heart rate captured by bedside ECG monitor
Physiologic Signal During Procedure: Blood Oxygen Saturation
时间窗: 1 minute during procedure
Blood oxygen saturation captured by bedside oximetry monitor
Audiovisual Signal After Procedure
时间窗: 1 minute immediately after procedure
Bedside recording using camera and microphone
Pain Score During Procedure
时间窗: 1 minute recording during procedure
Score provided by nurses from Neonatal Pain, Agitation \& Sedation Scale. Pain/Agitation scores range from 0-13, higher scores indicate higher pain/agitation levels.
Physiologic Signal After Procedure: Heart Rate
时间窗: 1 minute immediately after procedure
Heart rate captured by bedside ECG monitor
次要结局
未报告次要终点
研究者
Arthur Howard
Principal Investigator
Newcastle University