NCT07425418: BradenQDS

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

Recruiting now Last updated 20 February 2026

What this trial tests

trial in Pressure Ulcers in the Neonatal Population in 600 participants. Currently enrolling.

Timeline

1 July 2020

Primary endpoint
19 December 2027

19 April 2028

Quick facts

Lead sponsor	Fondazione IRCCS Policlinico San Matteo di Pavia
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	600
Start date	1 July 2020
Primary completion	19 December 2027
Estimated completion	19 April 2028
Sites	1 location across Italy

Conditions studied

• Pressure Ulcers in the Neonatal Population — all drugs for Pressure Ulcers in the Neonatal Population →

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Who can join

Under 28 Days, any sex, with Pressure Ulcers in the Neonatal Population. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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?

Publications & conference data

No peer-reviewed publications indexed yet for this trial.