Clinical trial NCT06037629: Premature Enhanced Automated Capture of Comfort Knowledge
Official title: Premature Enhanced Automated Capture of Comfort Knowledge (PEACOCK)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Pain
Pain, Procedural
Agitation
Discomfort
Lead sponsor: Newcastle University
Sponsor class: OTHER
Collaborators: name: Newcastle-upon-Tyne Hospitals NHS Trust
First posted: 2023-09-14
Enrollment: 100
Sex: ALL
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm neonates hospitalised in the Royal Victoria Infirmary Neonatal Intensive Care Unit

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Score Before Procedure
timeFrame: 1 minute recording before procedure
measure: Audiovisual signal Before Procedure
timeFrame: 1 minute starting before procedure
measure: Physiologic Signal Before Procedure: Heart Rate
timeFrame: 1 minute starting before procedure
measure: Physiologic Signal Before Procedure: Blood Oxygen Saturation
timeFrame: 1 minute starting before procedure
measure: Pain Score During Procedure
timeFrame: 1 minute recording during procedure
measure: Audiovisual Signal During Procedure
timeFrame: 1 minute during procedure
measure: Physiologic Signal During Procedure: Heart Rate
timeFrame: 1 minute during procedure
measure: Physiologic Signal During Procedure: Blood Oxygen Saturation
timeFrame: 1 minute during procedure
measure: Pain Score After Procedure
timeFrame: 1 minute recording immediately after procedure
measure: Audiovisual Signal After Procedure
timeFrame: 1 minute immediately after procedure
measure: Physiologic Signal After Procedure: Heart Rate
timeFrame: 1 minute immediately after procedure
measure: Physiologic Signal After Procedure: Blood Oxygen Saturation
timeFrame: 1 minute immediately after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals Nhs Foundation Trust
Study officials:
References: