Braden QD Scale for Pressure Ulcers in… (NCT07425418)

At a Glance

Age: Up to 28 Days
Sex: Any
Study type: Observational
Participants needed: 600 (estimated)
Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Other

Who this trial is looking for

This trial is looking for newborns under 28 days old who will participate in a study to test a scale for assessing the risk of pressure ulcers in a Neonatal Intensive Care Unit. Parents will need to provide informed consent for their newborn to join the study.

Are You a Good Fit for This Trial?

You may be able to join if

I am less than 28 days old
I weigh less than 5 kg
I have informed consent signed by both parents

You may not be able to join if

I am older than 28 days
I weigh more than 5 kg
I do not have informed consent from my parents

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

About This Trial

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 recomme…

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?

Trial Locations

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Eligibility Criteria

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 * age on admission of less than 28 days, * body weight on admission less than 5 kg, * informed consent complete…

Contacts

Giuseppina Grugnetti, MD

+39 0382501082

g.grugnetti@smatteo.pv.it

CONTACT

Braden QD Scale for Pressure Ulcers in Newborns

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