[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616281":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":22,"responsibleParty":34,"collaborators":36,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":7,"maxAge":7,"enrollmentInfo":50,"targetDuration":7,"studyType":53,"phases":7,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":24,"whyStopped":7,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Nottingham University Hospitals NHS Trust","OTHER",null,[9],{"name":10,"affiliation":11,"role":12},"Takawira C Marufu, Phd","Nottingham University Hospital","PRINCIPAL_INVESTIGATOR",[14,19],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Kathleen Holding, PhD","CONTACT","+44 115 92499240 ext. 83746","Kathleen.Holding@nhs.net",{"name":20,"role":16,"phone":7,"phoneExt":7,"email":21},"Noor Altameemi, MSc","n.altameemi@nhs.net",[23],{"facility":11,"status":24,"city":25,"state":7,"zip":7,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":7},"RECRUITING","Nottingham","United Kingdom","UK",{"type":29,"coordinates":30},"Point",[31,32],-1.15047,52.9536,{"lat":32,"lon":31},{"type":35,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[37,39],{"name":38,"class":6},"University of Leicester",{"name":40,"class":6},"University of Surrey","100616281","prevention-of-pressure-injury-pi-in-hospitalised-infants-children-and-young-people-cyp-aged-0-19-years-100616281",false,"NCT07303569","Prevention of Pressure Injury (PI) in Hospitalised Infants, Children, and Young People (CYP) (Aged 0-19 Years)","CYPPI","Inclusion Criteria:\n\nPhase 1\n\nHCP participants:\n\n1. Experts (e.g. tissue viability practitioners, dermatologist)\n2. HCP looking after hospitalised infants and CYP\n3. Able to give consent\n\nParent\u002F guardian participants:\n\n1. Parents\u002F guardians of infants and CYP admitted to hospital with or developed PI\n2. Parent\u002F 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.\n3. Able to give consent\n\nCYP participants:\n\n1. Age 10 - 19\n2. Dark skin tone according to Fitzpatrick Classification of Skin Types III, IV, V or VI.\n3. Able to gain consent\n4. Able to provide assent with parental consent\n5. Developed PI during hospitalisation Phase 2 Hospitalised infants and CYP participants\n\n1\\. 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.\n\nExclusion Criteria:\n\nPhase1:\n\nHCP participants:\n\n1. HCP not working with hospitalised infants and CYP.\n2. Unable to provide consent.\n\nParents participants:\n\n1. Parents of hospitalised infants and CYP with no PI.\n2. Unable to gain consent\n\nCYP participants:\n\n1. Not able to provide consent\n2. CYP with no PI during hospitalisation period Phase 2\n\n1\\. Admitted to hospital for less than 24 hrs 2. Unable to gain consent 3. Fitzpatrick Classification of Skin Types I, II or III",true,"ALL",{"count":51,"type":52},542,"ESTIMATED","OBSERVATIONAL","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.\n\nWhat 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.\n\nWhat 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.\n\nThis 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.\n\nHow are investigators going to do it?\n\nInvestigators will:\n\n1. 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.\n2. 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.",[56,57],"Pressure Injuries","Pressure Ulcers, Bedsores, Decubitus Ulcer",[59,60,61,62,63],"Pressure Injury prevention","assessment","tools (instruments)","Validity","Dark skin tone","2025-12-10",{"date":66,"type":67},"2025-12-26","ACTUAL",{"date":69,"type":67},"2025-07-30",{"date":71,"type":52},"2026-05-16",{"name":5,"class":6},1]