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NCT06037629 Clinical Trial

Premature Enhanced Automated Capture of Comfort Knowledge

Acute Pain Clinical Trial

— PEACOCK  

Official title:
Premature Enhanced Automated Capture of Comfort Knowledge (PEACOCK)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06037629
Other study ID # 299441
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date January 2024

Study information
Verified date September 2023
Source Newcastle University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to develop methods that could provide continual monitoring of comfort levels for preterm neonates in hospitals.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date January 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 37 Weeks
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom The Newcastle Upon Tyne Hospitals Nhs Foundation Trust Newcastle upon Tyne

Sponsors (2)
Lead Sponsor Collaborator
Newcastle University Newcastle-upon-Tyne Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

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