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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Acute Pain
• Agitation
• Discomfort
• Pain, Procedural

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