Premature Enhanced Automated Capture of Comfort Knowledge (PEACOCK)

Newcastle University

Status: Enrolling

Conditions: Agitation; Discomfort; Acute Pain; Pain, Procedural

Study type: Observational

Funder types: Other

Identifiers

NCT06037629

299441

Details and patient eligibility

About

The goal of this observational study is to develop methods that could provide continual monitoring of comfort levels for preterm neonates in hospitals.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 37 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Preterm neonates in intensive care

Description:

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