Clincosm LogoSign in Get a demo

PEACOCK: Premature Enhanced Automated Capture of Comfort Knowledge

Sponsor
Newcastle University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06037629
Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust (Other)
100
Enrollment
1
Location
11
Anticipated Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Premature Enhanced Automated Capture of Comfort Knowledge (PEACOCK)
    Actual Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jan 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Preterm neonates in intensive care

    Preterm neonates born <36 completed weeks of gestation with postmenstrual age <36 weeks

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. Audiovisual signal Before Procedure [1 minute starting before procedure]

      Bedside recording using camera and microphone.

    3. Physiologic Signal Before Procedure: Heart Rate [1 minute starting before procedure]

      Heart rate captured by bedside ECG monitor

    4. Physiologic Signal Before Procedure: Blood Oxygen Saturation [1 minute starting before procedure]

      Blood oxygen saturation captured by bedside oximetry monitor

    5. 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.

    6. Audiovisual Signal During Procedure [1 minute during procedure]

      Bedside recording using camera and microphone

    7. Physiologic Signal During Procedure: Heart Rate [1 minute during procedure]

      Heart rate captured by bedside ECG monitor

    8. Physiologic Signal During Procedure: Blood Oxygen Saturation [1 minute during procedure]

      Blood oxygen saturation captured by bedside oximetry monitor

    9. 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.

    10. Audiovisual Signal After Procedure [1 minute immediately after procedure]

      Bedside recording using camera and microphone

    11. Physiologic Signal After Procedure: Heart Rate [1 minute immediately after procedure]

      Heart rate captured by bedside ECG monitor

    12. Physiologic Signal After Procedure: Blood Oxygen Saturation [1 minute immediately after procedure]

      Blood oxygen saturation captured by bedside oximetry monitor

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 37 Weeks
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Newcastle Upon Tyne Hospitals Nhs Foundation Trust Newcastle upon Tyne United Kingdom NE1 4LP

    Sponsors and Collaborators

    • Newcastle University
    • Newcastle-upon-Tyne Hospitals NHS Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arthur Howard, Principal Investigator, Newcastle University
    ClinicalTrials.gov Identifier:
    NCT06037629
    Other Study ID Numbers:
    • 299441
    First Posted:
    Sep 14, 2023
    Last Update Posted:
    Sep 14, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acute Pain
    Pain, Procedural

    Study Results

    No Results Posted as of Sep 14, 2023