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Premature Enhanced Automated Capture of Comfort Knowledge

Premature Enhanced Automated Capture of Comfort Knowledge (PEACOCK)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06037629
Acronym
PEACOCK
Enrollment
100
Registered
2023-09-14
Start date
2023-02-01
Completion date
2024-01-31
Last updated
2023-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, Agitation, Discomfort, Pain, Procedural

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.

Interventions

None listed

Sponsors

Newcastle-upon-Tyne Hospitals NHS Trust
CollaboratorOTHER
Newcastle University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 37 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Score Before Procedure1 minute recording before procedureScore provided by nurses from Neonatal Pain, Agitation & Sedation Scale. Pain/Agitation scores range from 0-13, higher scores indicate higher pain/agitation levels.
Audiovisual signal Before Procedure1 minute starting before procedureBedside recording using camera and microphone.
Physiologic Signal Before Procedure: Heart Rate1 minute starting before procedureHeart rate captured by bedside ECG monitor
Physiologic Signal Before Procedure: Blood Oxygen Saturation1 minute starting before procedureBlood oxygen saturation captured by bedside oximetry monitor
Pain Score During Procedure1 minute recording during procedureScore provided by nurses from Neonatal Pain, Agitation & Sedation Scale. Pain/Agitation scores range from 0-13, higher scores indicate higher pain/agitation levels.
Audiovisual Signal During Procedure1 minute during procedureBedside recording using camera and microphone
Physiologic Signal During Procedure: Heart Rate1 minute during procedureHeart rate captured by bedside ECG monitor
Physiologic Signal During Procedure: Blood Oxygen Saturation1 minute during procedureBlood oxygen saturation captured by bedside oximetry monitor
Pain Score After Procedure1 minute recording immediately after procedureScore provided by nurses from Neonatal Pain, Agitation & Sedation Scale. Pain/Agitation scores range from 0-13, higher scores indicate higher pain/agitation levels.
Audiovisual Signal After Procedure1 minute immediately after procedureBedside recording using camera and microphone
Physiologic Signal After Procedure: Heart Rate1 minute immediately after procedureHeart rate captured by bedside ECG monitor
Physiologic Signal After Procedure: Blood Oxygen Saturation1 minute immediately after procedureBlood oxygen saturation captured by bedside oximetry monitor

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026