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Clinical trial Recruiting at 1 site Observational

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

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

Run by Nottingham University Hospitals NHS Trust · NCT07303569 · Data updated 2026-11-12

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.

More Pressure Injuries trials

Quick facts

Study typeObservational
SexAll
Enrollment542 (estimated)
SponsorNottingham University Hospitals NHS Trust
Academic / other
Locations1 site (Nottingham)
StatusRecruiting
StartedJuly 30, 2025
Main results expectedMay 16, 2026
Study endsMay 16, 2026
Registry record updatedDecember 26, 2025
Trial IDNCT07303569 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Nottingham University Hospital
    Nottingham, United Kingdom     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.