Acute PainPEACOCKNCT06037629
Premature Enhanced Automated Capture of Comfort Knowledge
An observational study of Acute Pain and Pain, Procedural, run by Newcastle University at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to develop methods that could provide continual monitoring of comfort levels for preterm neonates in hospitals. Read more about this study
- Who is it for?
- Ages Up to 37 weeks
- Conditions the study is for
- Acute Pain, Pain, Procedural, Agitation
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2023to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 37 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm neonates hospitalised in the Royal Victoria Infirmary Neonatal Intensive Care Unit
Who may be able to join
- Preterm Infants born <36 completed weeks of gestation
- Medically stable
- Written informed consent from parents
Who cannot join
- Infants with significant brain, spine, or congenital abnormality
- Parents unwilling to provide consent
- Infants with postmenstrual age >36 weeks
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust
Newcastle upon Tyne, NE1 4LP
Nicholas D Embleton, 01912825156, nicholas.embleton@ncl.ac.uk
About this study
Official title: Premature Enhanced Automated Capture of Comfort Knowledge (PEACOCK)
The goal of this observational study is to develop methods that could provide continual monitoring of comfort levels for preterm neonates in hospitals.
Read the 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.
- Conditions
- Acute Pain, Pain, Procedural, Agitation, Discomfort
- Medical subject headings
- Acute Pain, Pain, Procedural, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm neonates in intensive care | Preterm neonates born <36 completed weeks of gestation with postmenstrual age <36 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 minute recording before procedure
Audiovisual signal Before Procedure
Bedside recording using camera and microphone.
Measured: 1 minute starting before procedure
Physiologic Signal Before Procedure: Heart Rate
Heart rate captured by bedside ECG monitor
Measured: 1 minute starting before procedure
Physiologic Signal Before Procedure: Blood Oxygen Saturation
Blood oxygen saturation captured by bedside oximetry monitor
Measured: 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.
Measured: 1 minute recording during procedure
Audiovisual Signal During Procedure
Bedside recording using camera and microphone
Measured: 1 minute during procedure
Physiologic Signal During Procedure: Heart Rate
Heart rate captured by bedside ECG monitor
Measured: 1 minute during procedure
Physiologic Signal During Procedure: Blood Oxygen Saturation
Blood oxygen saturation captured by bedside oximetry monitor
Measured: 1 minute during procedure
Pain Score 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.
Measured: 1 minute recording immediately after procedure
Audiovisual Signal After Procedure
Bedside recording using camera and microphone
Measured: 1 minute immediately after procedure
Physiologic Signal After Procedure: Heart Rate
Heart rate captured by bedside ECG monitor
Measured: 1 minute immediately after procedure
Physiologic Signal After Procedure: Blood Oxygen Saturation
Blood oxygen saturation captured by bedside oximetry monitor
Measured: 1 minute immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Feb 2023
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust
- Responsible party
- Principal investigator, Arthur Howard, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037629
- Sponsor's protocol ID
- 299441
- Acronym
- PEACOCK
- Status last verified
- Sep 2023
- First submitted
- 29 Mar 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premature Enhanced Automated Capture of Comfort Knowledge (PEACOCK)
- ClinicalTrials.gov ID
- NCT06037629
- Acronym / sponsor ID
- PEACOCK / 299441
- Conditions
- Acute Pain, Pain, Procedural, Agitation, Discomfort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm neonates in intensive care | – | –Preterm neonates born <36 completed weeks of gestation with postmenstrual age <36 weeks |
Who may qualify
- Ages
- Up to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm neonates hospitalised in the Royal Victoria Infirmary Neonatal Intensive Care Unit
Key inclusion criteria (3 listed)
- Preterm Infants born <36 completed weeks of gestation
- Medically stable
- Written informed consent from parents
Key exclusion criteria (3 listed)
- Infants with significant brain, spine, or congenital abnormality
- Parents unwilling to provide consent
- Infants with postmenstrual age >36 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Score Before Procedure
Time frame: 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.
Audiovisual signal Before Procedure
Time frame: 1 minute starting before procedure
Bedside recording using camera and microphone.
Physiologic Signal Before Procedure: Heart Rate
Time frame: 1 minute starting before procedure
Heart rate captured by bedside ECG monitor
Physiologic Signal Before Procedure: Blood Oxygen Saturation
Time frame: 1 minute starting before procedure
Blood oxygen saturation captured by bedside oximetry monitor
Pain Score During Procedure
Time frame: 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.
Audiovisual Signal During Procedure
Time frame: 1 minute during procedure
Bedside recording using camera and microphone
Physiologic Signal During Procedure: Heart Rate
Time frame: 1 minute during procedure
Heart rate captured by bedside ECG monitor
Physiologic Signal During Procedure: Blood Oxygen Saturation
Time frame: 1 minute during procedure
Blood oxygen saturation captured by bedside oximetry monitor
Pain Score After Procedure
Time frame: 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.
Audiovisual Signal After Procedure
Time frame: 1 minute immediately after procedure
Bedside recording using camera and microphone
Physiologic Signal After Procedure: Heart Rate
Time frame: 1 minute immediately after procedure
Heart rate captured by bedside ECG monitor
Physiologic Signal After Procedure: Blood Oxygen Saturation
Time frame: 1 minute immediately after procedure
Blood oxygen saturation captured by bedside oximetry monitor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust
Newcastle upon Tyne, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pain and Pain, Procedural, run by Newcastle University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score Before Procedure (time frame: 1 minute recording before procedure). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.