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Study identifier: NCT07425418 Synced from ClinicalTrials.gov · July 29, 2026
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Italian Validation of a Pressure Injury Risk Assessment Scale (Braden QDS) in the Neonatal Intensive Care Unit

Condition: Pressure Ulcers in the Neonatal Population  ·  Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

PhaseN/A
Planned participants600
Who can joinAll sexes, N/A to 28 Days
Healthy volunteersNo

About this study

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. …

This description comes directly from the study's public registry record.

Talk to the study team

Giuseppina Grugnetti, MD  ·  +39 0382501082  ·  g.grugnetti@smatteo.pv.it

Always discuss trial participation with your own doctor first.

Locations (1)

Fondazione IRCCS Policlinico San Matteo di PaviaPavia, Pavia, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT07425418