Preventing pressure injuries in hospitalized infants, children, and young people (0–19 years) with darker skin tones

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

This project will test whether a modified BRADEN-QD tool better identifies pressure injury risk in hospitalized infants, children, and young people with darker skin tones.

Quick facts

• Study type: Observational
• Enrollment: 542 (estimated)
• Sex: All
• Sponsor: Nottingham University Hospitals NHS Trust (Academic / other)
• Locations: 1 site (Nottingham)
• Trial ID: NCT07303569 on ClinicalTrials.gov

What this trial studies

This mixed-methods program first gathers input from clinicians, parents, and older children through interviews and online workshops to identify additional pressure-injury risk items relevant to darker skin tones, using a nominal group technique and a modified Delphi process with ≥70% consensus to create a modified BRADEN-QD (mBRADEN-QD). In phase two the original and/or modified BRADEN-QD will undergo multicentre psychometric validation in hospitalized infants and children with darker skin (Fitzpatrick types IV–VI). Data collection includes qualitative interviews, ranked item consensus, and prospective bedside assessments across participating centres. The goal is to determine whether the tool needs modification and to validate its accuracy for detecting pressure injury risk in this population.

Who should consider this trial

Good fit: Ideal participants are hospitalized infants, children, and young people aged 0–19 years with darker skin tones (typically Fitzpatrick types IV–VI) who are admitted for at least 24 hours and are at risk of or have developed pressure injuries.

Not a fit: Patients without darker skin tones, those not hospitalized at participating sites, or individuals with advanced, already-established pressure injuries unlikely to be preventable may not benefit from this prevention-focused work.

Why it matters

Potential benefit: If successful, the modified tool could help clinicians identify pressure injury risk earlier in children with darker skin tones, reducing sores, treatments, and related distress for families.

How similar studies have performed: Existing risk-assessment tools for pressure injury exist, but few have been specifically validated or modified for children with darker skin tones, so this work addresses a largely untested gap.

Eligibility criteria

Inclusion Criteria:

Phase 1

HCP participants:

1. Experts (e.g. tissue viability practitioners, dermatologist)
2. HCP looking after hospitalised infants and CYP
3. Able to give consent

Parent/ guardian participants:

1. Parents/ guardians of infants and CYP admitted to hospital with or developed PI
2. 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.
3. Able to give consent

CYP participants:

1. Age 10 - 19
2. Dark skin tone according to Fitzpatrick Classification of Skin Types III, IV, V or VI.
3. Able to gain consent
4. Able to provide assent with parental consent
5. Developed PI during hospitalisation Phase 2 Hospitalised infants and CYP participants

1\. Infants and CYP admitted to hospital for 24 hrs 2. Age 0-19 years 3. Able to gain consent. 4. Fitzpatrick Classification of Skin Types IV, V or VI.

Exclusion Criteria:

Phase1:

HCP participants:

1. HCP not working with hospitalised infants and CYP.
2. Unable to provide consent.

Parents participants:

1. Parents of hospitalised infants and CYP with no PI.
2. Unable to gain consent

CYP participants:

1. Not able to provide consent
2. CYP with no PI during hospitalisation period Phase 2

1\. Admitted to hospital for less than 24 hrs 2. Unable to gain consent 3. Fitzpatrick Classification of Skin Types I, II or III

Where this trial is running

Nottingham

• Nottingham University Hospital — Nottingham, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Takawira C Marufu, Phd — Nottingham University Hospital
• Study coordinator: Kathleen Holding, PhD

Conditions Pressure Injuries; Pressure Ulcers, Bedsores, Decubitus Ulcer; Pressure Injury prevention; assessment; tools; Validity; Dark skin tone