Premature Enhanced Automated Capture of Comfort Knowledge

Recruiting

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

• Registration Number: NCT06037629
• Lead Sponsor: Newcastle University

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.

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-03-29
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-07
• Last Update Submitted: 2023-09-07
• Study First Posted: 2023-09-14
• Last Update Posted: 2023-09-14
• Primary Completion: 2024-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

The Newcastle Upon Tyne Hospitals Nhs Foundation Trust; 🇬🇧 Newcastle upon Tyne, United Kingdom