RecruitingNot Applicable

Italian Validation of a Pressure Injury Risk Assessment Scale (Braden QDS) in the Neonatal Intensive Care Unit

Italy600 participantsStarted 2020-07-01

Plain-language summary

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?

Who can participate

Age range

28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 completed and signed by both parents. In the case of a newborn child recognised by only one parent, the signature and consent of only one of them, the one who recognises the newborn child, will be sufficient. Exclusion Criteria: * age greater than 28 days at the time of admission to the NICU * weight greater than 5 kg at the time of admission to the NICU - Lack of Informed Consent from Parents

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

.Braden QDS Linguistic-cultural validation (Italian Version)

Timeframe: Study duration 21 months Enrolment duration 18 months Planned monitoring is quarterly and internal

Trial details

NCT IDNCT07425418

SponsorFondazione IRCCS Policlinico San Matteo di Pavia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-19

Contact for this trial

Giuseppina Grugnetti, MD

+39 0382501082 g.grugnetti@smatteo.pv.it

View on ClinicalTrials.gov More Pressure Ulcers in the Neonatal Population trials