Premature Enhanced Automated Capture of Comfort Knowledge (PEACOCK)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Pain
- Sponsor
- Newcastle University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Physiologic Signal Before Procedure: Heart Rate
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this observational study is to develop methods that could provide continual monitoring of comfort levels for preterm neonates in hospitals.
Detailed Description
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.
Investigators
Arthur Howard
Principal Investigator
Newcastle University
Eligibility Criteria
Inclusion Criteria
- •Preterm Infants born \<36 completed weeks of gestation
- •Medically stable
- •Written informed consent from parents
Exclusion Criteria
- •Infants with significant brain, spine, or congenital abnormality
- •Parents unwilling to provide consent
- •Infants with postmenstrual age \>36 weeks
Outcomes
Primary Outcomes
Physiologic Signal Before Procedure: Heart Rate
Time Frame: 1 minute starting before procedure
Heart rate captured by bedside ECG monitor
Audiovisual signal Before Procedure
Time Frame: 1 minute starting before procedure
Bedside recording using camera and microphone.
Audiovisual Signal During Procedure
Time Frame: 1 minute during procedure
Bedside recording using camera and microphone
Pain Score Before Procedure
Time Frame: 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
Time Frame: 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
Time Frame: 1 minute immediately after procedure
Blood oxygen saturation captured by bedside oximetry monitor
Physiologic Signal Before Procedure: Blood Oxygen Saturation
Time Frame: 1 minute starting before procedure
Blood oxygen saturation captured by bedside oximetry monitor
Physiologic Signal During Procedure: Heart Rate
Time Frame: 1 minute during procedure
Heart rate captured by bedside ECG monitor
Physiologic Signal During Procedure: Blood Oxygen Saturation
Time Frame: 1 minute during procedure
Blood oxygen saturation captured by bedside oximetry monitor
Audiovisual Signal After Procedure
Time Frame: 1 minute immediately after procedure
Bedside recording using camera and microphone
Pain Score During Procedure
Time Frame: 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
Time Frame: 1 minute immediately after procedure
Heart rate captured by bedside ECG monitor