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| Name | Class |
|---|---|
| Newcastle-upon-Tyne Hospitals NHS Trust | OTHER |
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The goal of this observational study is to develop methods that could provide continual monitoring of comfort levels for preterm neonates in hospitals.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preterm neonates in intensive care | Preterm neonates born <36 completed weeks of gestation with postmenstrual age <36 weeks |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Preterm neonates hospitalised in the Royal Victoria Infirmary Neonatal Intensive Care Unit
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Newcastle Upon Tyne Hospitals Nhs Foundation Trust | Recruiting | Newcastle upon Tyne | NE1 4LP | United Kingdom |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D000073818 | Pain, Procedural |
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| D020820 | Dyskinesias |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |