Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, 27100, Italy
Location status: Recruiting
NCT Number: NCT07425418
In the pediatric field, especially in newborns, the appearance of pressure ulcers is a very frequent event, with prolonged hospitalization, increased costs and worsening of the newborn's clinical picture National data on the prevalence and incidence of pressure ulcers (LP) are not easily available, especially if referred to pediatric and neonatal settings; However, there are guidelines and recommendations issued by scientific societies based on national data on an adult population.
The guidelines produced by NPUAP and EPUAP underline the importance of using a tool to assess the risk of pressure ulcers that includes, among the items, the presence of a device as a favorable factor. However, the scales most used in the pediatric/neonatal field for risk assessment do not include it. These scales are the Braden Q Scale, the Glamorgan Scale and the NSRAS
The overall objective of this Single-Centre Observational study is to describe the validity and reliability of the Braden QD Scale (Italian version) in the neonatal population.
Population enrolled:
Newborns who will be part of the Braden QD Scale validation study will be placed in the standard Neonatal Intensive Care Unit (NICU) setting; they will then be admitted to the OU in a thermocot, cot or neonatal island. All devices are provided with an anti-decubitus mattress certified by the manufacturers; in addition, all newborns are placed under the head with a water or gel mattress to further reduce the risk of pressure injury.
* Newborns admitted to the Neonatal Intensive Care Unit (NICU) who are less than 28 days old at the time of admission, * Newborns with a body weight of less than 5 kg, at the time of admission
The main questions it aims to answer are:
* Is the Braden QD Scale the optimal instrument for detecting the risk of pressure injury, in such a complex context as that of the Neonatal Intensive Care Unit? * Can the Braden QD Scale detect and measure the risk of pressure injuries from devices placed on the Neonate?
Interested in participating?
Request InfoUp to 28 day
All sexes
Observational
Pavia, 27100, Italy
Location status: Recruiting
Infants who will be part of the Braden QD Scale validation study will be placed in the standard Neonatal Intensive Care Unit (NICU) setting; they will then be admitted to the OU in a thermocot, cot or neonatal island. All devices are provided with an anti-decubitus mattress certified by the manufacturers; in addition, all newborns are placed under the head with a water or gel mattress to further reduce the risk of pressure injury. The fabric used in the incubators and other equipment is standard, supplied by the Fondazione I.R.C.S. Policlinico San Matteo di Pavia and from a single company for both washing and rental. As per the protocol in use within the UOC and in accordance with international literature, the newborns undergo a change of posture or decubitus every 2/3 hours.
All first surveys will be carried out after the hygienic care of the newborn, in the morning shift. During the first survey, operator A will carry out an assessment during hygienic care, an ideal time to observe the infant's skin integrity; operator B will carry out the assessment 6 hours after operator A who, in turn, will repeat it again within 12 hours.
With this scheme, the maximum duration of measurements will be 28 days or until discharge, whichever comes first.
The appearance of pressure lesions will be grounds for discontinuing the measurements.
A construct correlation will be performed between the Braden QD Italian version scale and the Neonatal Skin Risk Assessment Scale (NSRAS) (Lund, C.H. & Osborne, J.W. (2004; Dolack et al., 2013) original version in the first assessment of the first 100 infants.
The nurses involved will be previously trained in filling in the scale for a period of approximately 15 days, during which a number of clinical cases will be developed to be assessed and analysed in teams, with the aim of improving knowledge of the scale and making its filling in correct and uniform.
The professionals involved will also be shown in advance the author's video tutorial in which she explains, through a detailed description of the items and practical cases, how to fill in the scale, eliminating any further doubts about its compilation. The video tutorial will be translated into Italian and a presentation will be created in order to train the entire nursing team.
The professionals The aim of this observational study is to validate the Braden QD Scale (Linguistic-Cultural and Construct Validation) to assess the risk of pressure injuries in the neonatal population.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The criteria for the inclusion of newborn babies correspond to the eligibility criteria for admission, in accordance with current company protocols, which provide for
Exclusion criteria
Time frame: Study duration 21 months Enrolment duration 18 months Planned monitoring is quarterly and internal
The study will be developed in three phases: the first, that of linguistic-cultural validation, will be based on the standard methodology of 'translation, back-translation and foreward translation', carried out by independent and expert English language operators. The final version will be judged by Expert Health Professionals and evaluated by means of a 4-step Likert Scale, where 1 = not at all agree and 4 = completely agree. The achievement of translation agreement will be objectified through the calculation of Fleiss' K-index, setting a value of 0.7 as cut-off.
The second phase will be that of content and face validation, through the calculation of the Content Validity Ratio (CVR) by submitting the scale to healthcare professionals who, through a 4-step Likert scale, will assess the relevance of each item in relation to the objective.
The third and final phase will consist in the evaluation of the psychometric properties and reliability of the scale, described in the analysis plan
Contact information is provided by the study sponsor or research team.
Fondazione IRCCS Policlinico San Matteo di Pavia
Other
Acronym: BradenQDS
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