Premature Enhanced Automated Capture of Comfort Knowledge

Study 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.

Official Title
-----------------
Premature Enhanced Automated Capture of Comfort Knowledge (PEACOCK)

Conditions
-----------------
Acute Pain, Pain, Procedural, Agitation, Discomfort

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 37 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm neonates in intensive care<br>Preterm neonates born <36 completed weeks of gestation with postmenstrual age <36 weeks | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score 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. | 1 minute recording before procedure | 
| Audiovisual signal Before Procedure | Bedside recording using camera and microphone. | 1 minute starting before procedure | 
| Physiologic Signal Before Procedure: Heart Rate | Heart rate captured by bedside ECG monitor | 1 minute starting before procedure | 
| Physiologic Signal Before Procedure: Blood Oxygen Saturation | Blood oxygen saturation captured by bedside oximetry monitor | 1 minute starting before procedure | 
| Pain Score 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. | 1 minute recording during procedure | 
| Audiovisual Signal During Procedure | Bedside recording using camera and microphone | 1 minute during procedure | 
| Physiologic Signal During Procedure: Heart Rate | Heart rate captured by bedside ECG monitor | 1 minute during procedure | 
| Physiologic Signal During Procedure: Blood Oxygen Saturation | Blood oxygen saturation captured by bedside oximetry monitor | 1 minute during procedure | 
| Pain Score 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. | 1 minute recording immediately after procedure | 
| Audiovisual Signal After Procedure | Bedside recording using camera and microphone | 1 minute immediately after procedure | 
| Physiologic Signal After Procedure: Heart Rate | Heart rate captured by bedside ECG monitor | 1 minute immediately after procedure | 
| Physiologic Signal After Procedure: Blood Oxygen Saturation | Blood oxygen saturation captured by bedside oximetry monitor | 1 minute immediately after procedure |