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Healthy Volunteers
NCT07303569

Prevention of Pressure Injury (PI) in Hospitalised Infants, Children, and Young People (CYP) (Aged 0-19 Years)

Led by Nottingham University Hospitals NHS Trust · Updated on 2025-12-26

542

Participants Needed

1

Research Sites

41 weeks

Total Duration

On this page

Sponsors

N

Nottingham University Hospitals NHS Trust

Lead Sponsor

U

University of Leicester

Collaborating Sponsor

AI-Summary

What this Trial Is About

What is the problem? Children and young people admitted to hospital can sometimes be harmed by what is called a pressure injury. Pressure injuries are sores (ulcers) that happen on areas of the skin that are under pressure. The pressure can come from lying in bed, sitting in a wheelchair, or wearing a cast for a long time. They usually form on bony parts of the body, such as the heels, elbows, hips, and tailbone. This can be uncomfortable for the patient and distressing for their families. As well, it means that more staff and treatments are needed for the patient. What is known? There is a difference in pressure injury seriousness for infants and children with dark skin tones to those without. Pressure injury care for hospitalised patients starts with an assessment using a tool. In the past, the assessment tools were developed without consideration for differences due to skin tone. This means that the current tools may not be the best way to identify pressure injury for dark skin tones. Healthcare professionals need to make sure that tools are fit for purpose for all. What are investigators going to do? Investigators will work with healthcare professionals, children, and parents together to develop and test the existing pressure injury risk assessment tool for use with dark skin tones. This study is a result of care priority discussions with parents and children. It came from the patients and will benefit the patients. Children, young people, and parents will be involved throughout to ensure their voices are heard. How are investigators going to do it? Investigators will: 1. Look at existing information about pressure injury for children with darker skin tones. If required, investigators will change and increase the accuracy of the existing tool. 2. Test the modified risk assessment tool at 10 children's hospitals in the UK. Investigators will do this to see if it can distinguish hospitalised children with dark skin tones, at high or low risk of pressure injury development during their hospital stay.

CONDITIONS

Official Title

Prevention of Pressure Injury (PI) in Hospitalised Infants, Children, and Young People (CYP) (Aged 0-19 Years)

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthcare professionals who care for hospitalised infants and children and can give consent
  • Parents or guardians of hospitalised infants and children under 19 years with dark skin tones (Fitzpatrick Skin Types III, IV, V, or VI) who can give consent
  • Children and young people aged 10 to 19 years with dark skin tones (Fitzpatrick Skin Types III, IV, V, or VI), able to provide assent and parental consent, who developed a pressure injury during hospitalisation
  • Hospitalised infants and children aged 0 to 19 years admitted for at least 24 hours with dark skin tones (Fitzpatrick Skin Types IV, V, or VI) able to give consent
Not Eligible

You will not qualify if you...

  • Healthcare professionals not working with hospitalised infants and children or unable to provide consent
  • Parents of hospitalised infants and children without pressure injuries or unable to give consent
  • Children and young people unable to provide consent or without pressure injuries during hospitalisation
  • Infants and children admitted to hospital for less than 24 hours
  • Individuals unable to provide consent
  • Individuals with Fitzpatrick Skin Types I, II, or III (in Phase 2)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Nottingham University Hospital

Nottingham, United Kingdom

Actively Recruiting

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Research Team

K

Kathleen Holding, PhD

CONTACT

N

Noor Altameemi, MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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