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

NCT07303569 | Recruiting

• 1 other identifier: 24CS003
• Study Type: observational
• Target: 542
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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

Pressure Injuries; Pressure Ulcers, Bedsores, Decubitus Ulcer

Keywords

Pressure Injury prevention; assessment; tools (instruments); Validity; Dark skin tone

Outcome Measures

Primary Outcomes (2)

• 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

  up to 4 weeks

• Pressure Injury development

  Developing a pressure injury while in hospital.

  up to 4 weeks

Secondary Outcomes (4)

• Length of hospital stay (LOS)

  up to 24 weeks

• Morbidity

  Up to 4 weeks

• Mortality

  up to 4 weeks

• Economic impact

  Up to 4 weeks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Phase 1
• HCP participants:
• Experts (e.g. tissue viability practitioners, dermatologist)
• HCP looking after hospitalised infants and CYP
• Able to give consent
• Parent/ guardian participants:
• Parents/ guardians of infants and CYP admitted to hospital with or developed PI
• Parent/ guardian of a CYP under 19 years of age with dark skin tone according to Fitzpatrick Classification of Skin Types III, IV, V or VI.
• Able to give consent
• CYP participants:
• Age 10 - 19
• Dark skin tone according to Fitzpatrick Classification of Skin Types III, IV, V or VI.
• Able to gain consent
• Able to provide assent with parental consent
• Developed PI during hospitalisation Phase 2 Hospitalised infants and CYP participants

You may not qualify if:

• Phase1:
• HCP participants:
• HCP not working with hospitalised infants and CYP.
• Unable to provide consent.
• Parents participants:
• Parents of hospitalised infants and CYP with no PI.
• Unable to gain consent
• CYP participants:
• Not able to provide consent
• CYP with no PI during hospitalisation period Phase 2
• \. Admitted to hospital for less than 24 hrs 2. Unable to gain consent 3. Fitzpatrick Classification of Skin Types I, II or III

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead
• University of Leicester: collaborator
• University of Surrey: collaborator

Study Sites (1)

Nottingham University Hospital

Nottingham, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Takawira C Marufu, Phd

  Nottingham University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Holding, PhD

CONTACT

+44 115 92499240 ext. 83746; Kathleen.Holding@nhs.net

Noor Altameemi, MSc

CONTACT

n.altameemi@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: December 26, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): May 16, 2026
• Study Completion (Estimated): May 16, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-10

Locations

GB (1)