Premature Enhanced Automated Capture of Comfort Knowledge

Newcastle University100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Acute Pain Pain, Procedural Agitation Discomfort

Eligibility

Sex: ALLMax age: 37 Weeks

Medical Language ↔ Plain English

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

Locations (1)

The Newcastle Upon Tyne Hospitals Nhs Foundation Trust

Newcastle upon Tyne, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 1 minute recording before procedure

Audiovisual signal Before Procedure

Bedside recording using camera and microphone.

Time frame: 1 minute starting before procedure

Physiologic Signal Before Procedure: Heart Rate

Heart rate captured by bedside ECG monitor

Time frame: 1 minute starting before procedure

Physiologic Signal Before Procedure: Blood Oxygen Saturation

Blood oxygen saturation captured by bedside oximetry monitor

Time frame: 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.

Time frame: 1 minute recording during procedure

Audiovisual Signal During Procedure

Bedside recording using camera and microphone

Time frame: 1 minute during procedure

Physiologic Signal During Procedure: Heart Rate

Heart rate captured by bedside ECG monitor

Time frame: 1 minute during procedure

Physiologic Signal During Procedure: Blood Oxygen Saturation

Blood oxygen saturation captured by bedside oximetry monitor

Data from ClinicalTrials.gov

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