Premature Enhanced Automated Capture of Comfort Knowledge (PEACOCK)

Premature Enhanced Automated Capture of Comfort Knowledge (PEACOCK)

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

Study Overview

• Status: Recruiting
• Conditions: Acute Pain; Pain, Procedural; Agitation; Discomfort

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United Kingdom
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Recruiting
    • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
    • Contact: Nicholas D Embleton; Phone Number: 01912825156; Email: nicholas.embleton@ncl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Preterm neonates hospitalised in the Royal Victoria Infirmary Neonatal Intensive Care Unit

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Preterm neonates in intensive care; 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

Collaborators and Investigators

• Sponsor: Newcastle University
• Collaborators: Newcastle-upon-Tyne Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Pain, Procedural
• Other Study ID Numbers: 299441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No