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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorNottingham University Hospitals NHS Trust

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Experts (e.g. tissue viability practitioners, dermatologist)

HCP looking after hospitalised infants and CYP

Able to give consent

Parents/ guardians of infants and CYP admitted to hospital with or developed PI

Disqualifiers

HCP not working with hospitalised infants and CYP.

Unable to provide consent.

Parents of hospitalised infants and CYP with no PI.

Unable to gain consent

Trial population

Phase 1: Healthcare professionals who look after infants, children and young people in hospital (children's nurses and doctors from various clinical areas, dermatologist, tissue viability practitioners and clinical educators); parents/ guardians of children who have a dark skin tone, have developed a pressure injury(s) while in hospital before, and children and young people with dark skin tones who have developed pressure injury(s) while in hospital before. Phase 2: Children and young people with dark skin tone admitted to hospital.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Total PI risk assessment score measured using the BRADEN-QD scale with or without additional items

Total PI risk assessment score. The scale uses a 0 to 20 point scale, with scores of 13 or higher indicating a patient is at risk for a PI

Time frame
up to 4 weeks
2

Pressure Injury development

Developing a pressure injury while in hospital.

Time frame
up to 4 weeks

Secondary outcomes

1

Length of hospital stay (LOS)

Number of days in hospital

Time frame
up to 24 weeks
2

Morbidity

Complications experienced while in hospital

Time frame
Up to 4 weeks
3

Mortality

Deaths while in hospital

Time frame
up to 4 weeks
4

Economic impact

Estimated treatment costs from pressure injury

Time frame
Up to 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nottingham University Hospitals NHS Trust

Lead sponsor

University of Leicester

Collaborator

University of Surrey

Collaborator