Premature Enhanced Automated Capture of Comfort Knowledge

NCT ID: NCT06037629

Last Updated: 2023-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-01-31

Brief Summary

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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

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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

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Acute Pain Pain, Procedural Agitation Discomfort

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Preterm neonates in intensive care

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

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Newcastle University

OTHER

Sponsor Role lead

Responsible Party

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Arthur Howard

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Newcastle Upon Tyne Hospitals Nhs Foundation Trust

Newcastle upon Tyne, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Nicholas D Embleton

Role: primary

01912825156

Other Identifiers

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299441

Identifier Type: -

Identifier Source: org_study_id

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