Pressure InjuriesCYPPINCT07303569
Prevention of Pressure Injury (PI) in Hospitalised Infants, Children, and Young People (CYP) (Aged 0-19 Years)
An observational study of Pressure Injuries and Pressure Ulcers, Bedsores, Decubitus Ulcer, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pressure Injuries, Pressure Ulcers, Bedsores, Decubitus Ulcer
- How many people
- 542 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jul 2025to 16 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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:
Show all 16Show fewer
- 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
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- Unable to gain consent
- CYP participants:
- Not able to provide consent
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Noor Altameemi, MSc contact
United Kingdom1 site, 1 recruiting
- Recruiting
Nottingham University Hospital
Nottingham
About this study
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.
Read more
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:
- 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.
- 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.
Read the detailed description
Research Question/Aim(s): How accurate is the BRADEN-QD in capturing risk of pressure injury (PI) in hospitalised infants and children and young people (CYP) with dark skin tones (DST)? Aim: To evaluate critical gaps in knowledge and evidence by modification (as required) and validation of the BRADEN-QD in hospitalised infants and CYP with DST.
Objectives:
- To identify and gain consensus on additional factors pertinent to hospitalised CYP with DST for inclusion in the BRADEN-QD [Phase 1].
- To validate the original/modified BRADEN-QD in a DST population through multi-centre study [Phase 2].
Study Design This is a mixed methods sequential study comprising of two phases; Phase 1 (information gathering) consists of two Work Packages (WPs 1 and 2). WP1: Individual interviews or focus groups with stakeholders to identify further PI risk items not captured from the literature. Interviews will be conducted online, over the telephone or face-to-face according to participant preference. Interviews will be audio recorded and transcribed verbatim.
WP2: Participants from stage 1 are invited to take part in a 60-minute Nominal Group Technique online workshop to rank, according to relevance and importance, the PI risk items identified from stage 1. A modified Delphi technique will be used and items with a consensus of ≥ 70% will be added to the BRADEN-QD to create a modified BRADEN-QD (mBRADEN-QD).
Study Phase 2; A multicentre pyschometric validation approach will be used to assess the accuracy and validity of the original tool (BRADEN-QD) or modified BRADEN-QD tool (mBRADEN-QD), based on Phase 1 findings.
Study Participants Phase 1: WP1 and WP2: Healthcare professionals (HCP), Children and young people (CYP), and parents/ guardians.
Phase 2: Hospitalised CYP with dark skin tone. Planned Size of Sample (if applicable) Phase 1: WP1 total participants 20 (7 CYP, 7 parents/ guardians and 6 HCP). WP2 participants from WP1 will be invited to take part. A minimum of 10 participants required.
Phase 2: A total of 522 participants will be recruited into the study across 10 sites. Each site will be expected to recruit a total of 52 participants.
Follow up duration (if applicable): Phase 2 For participants recruited for Phase 2, PI assessment is to be completed three times per week (Monday, Wednesday and Friday) for two full weeks and then once weekly for two weeks = maximum 8 times total follow up. Subject data will be considered complete at discharge or hospital day 28 after enrolment into the study whichever occur first. Any identified hospital acquired pressure injuries (HAPIs) will be categorised according to stage and causation. HAPIs will be managed at the discretion of the clinical team.
- Keywords
- Pressure Injury prevention, assessment, tools (instruments), Validity, Dark skin tone
- Medical subject headings
- Pressure Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 4 weeks
Pressure Injury development
Developing a pressure injury while in hospital.
Measured: up to 4 weeks
Secondary outcomes (4)
Length of hospital stay (LOS)
Number of days in hospital
Measured: up to 24 weeks
Morbidity
Complications experienced while in hospital
Measured: Up to 4 weeks
Mortality
Deaths while in hospital
Measured: up to 4 weeks
Economic impact
Estimated treatment costs from pressure injury
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start30 Jul 2025
- Primary completion16 May 2026 (estimated)
- Study completion16 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 542 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leicester, University of Surrey
- Responsible party
- Sponsor
- Investigators
- Takawira C Marufu, Phd, Principal investigator, Nottingham University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303569
- Sponsor's protocol ID
- 24CS003
- Acronym
- CYPPI
- Status last verified
- Oct 2025
- First submitted
- 19 Sep 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Pressure Injury (PI) in Hospitalised Infants, Children, and Young People (CYP) (Aged 0-19 Years)
- ClinicalTrials.gov ID
- NCT07303569
- Acronym / sponsor ID
- CYPPI / 24CS003
- Keywords
- Pressure Injury prevention, assessment, tools (instruments), Validity, Dark skin tone
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 542 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Leicester, University of Surrey
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 16 May 2026 (estimated)
- Study completion
- 16 May 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Detailed description
Research Question/Aim(s): How accurate is the BRADEN-QD in capturing risk of pressure injury (PI) in hospitalised infants and children and young people (CYP) with dark skin tones (DST)? Aim: To evaluate critical gaps in knowledge and evidence by modification (as required) and validation of the BRADEN-QD in hospitalised infants and CYP with DST.
Objectives:
- To identify and gain consensus on additional factors pertinent to hospitalised CYP with DST for inclusion in the BRADEN-QD [Phase 1].
- To validate the original/modified BRADEN-QD in a DST population through multi-centre study [Phase 2].
Study Design This is a mixed methods sequential study comprising of two phases; Phase 1 (information gathering) consists of two Work Packages (WPs 1 and 2). WP1: Individual interviews or focus groups with stakeholders to identify further PI risk items not captured from the literature. Interviews will be conducted online, over the telephone or face-to-face according to participant preference. Interviews will be audio recorded and transcribed verbatim.
WP2: Participants from stage 1 are invited to take part in a 60-minute Nominal Group Technique online workshop to rank, according to relevance and importance, the PI risk items identified from stage 1. A modified Delphi technique will be used and items with a consensus of ≥ 70% will be added to the BRADEN-QD to create a modified BRADEN-QD (mBRADEN-QD).
Study Phase 2; A multicentre pyschometric validation approach will be used to assess the accuracy and validity of the original tool (BRADEN-QD) or modified BRADEN-QD tool (mBRADEN-QD), based on Phase 1 findings.
Study Participants Phase 1: WP1 and WP2: Healthcare professionals (HCP), Children and young people (CYP), and parents/ guardians.
Phase 2: Hospitalised CYP with dark skin tone. Planned Size of Sample (if applicable) Phase 1: WP1 total participants 20 (7 CYP, 7 parents/ guardians and 6 HCP). WP2 participants from WP1 will be invited to take part. A minimum of 10 participants required.
Phase 2: A total of 522 participants will be recruited into the study across 10 sites. Each site will be expected to recruit a total of 52 participants.
Follow up duration (if applicable): Phase 2 For participants recruited for Phase 2, PI assessment is to be completed three times per week (Monday, Wednesday and Friday) for two full weeks and then once weekly for two weeks = maximum 8 times total follow up. Subject data will be considered complete at discharge or hospital day 28 after enrolment into the study whichever occur first. Any identified hospital acquired pressure injuries (HAPIs) will be categorised according to stage and causation. HAPIs will be managed at the discretion of the clinical team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- Phase 1
- 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
Key exclusion criteria (11 listed)
- 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
- Not able to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total PI risk assessment score measured using the BRADEN-QD scale with or without additional items
Time frame: up to 4 weeks
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
Pressure Injury development
Time frame: up to 4 weeks
Developing a pressure injury while in hospital.
4 secondary outcomes
Length of hospital stay (LOS)
Time frame: up to 24 weeks
Morbidity
Time frame: Up to 4 weeks
Mortality
Time frame: up to 4 weeks
Economic impact
Time frame: Up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Noor Altameemi, MSc contact
Takawira C Marufu, Phd principal investigator
Nottingham University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Injuries and Pressure Ulcers, Bedsores, Decubitus Ulcer, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Holding, PhD (+44 115 92499240 ext. 83746, Kathleen.Holding@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total PI risk assessment score measured using the BRADEN-QD scale with or without additional items (time frame: up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.