Pressure Ulcers in the Neonatal PopulationBradenQDSNCT07425418
Italian Validation of a Pressure Injury Risk Assessment Scale (Braden QDS) in the Neonatal Intensive Care Unit
An observational study of Pressure Ulcers in the Neonatal Population, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Pressure Ulcers in the Neonatal Population
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2020to 19 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: A convenience sample consisting of infants admitted to the IRCCS Policlinico San Matteo Foundation in Pavia in the Neonatal Intensive Care Unit and Neonatal Pathology Unit will be enrolled. 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. 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. There are cases of delayed postural change linked to the patient's difficulty in maintaining stable vital parameters, which will be reported appropriately in the data collection form. In the 30 minutes following
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, 27100
Giuseppina Grugnetti, MD, +39 0382501082, g.grugnetti@smatteo.pv.it
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
Read more
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?
Read the detailed description
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.
- In the 30 minutes following the meal, the infants are placed in the anti-reflux position, tilting the table about 30°, in order to facilitate gastric emptying and reduce the risk of reflux or regurgitation
- The first measurement of the scale will be carried out, after enrolment and assessment of the hydration status of the skin according to the rating scale in use in the Foundation, following morning hygiene care and the second assessment by the end of the daily shift (maximum within 6 hours) on the day of enrolment, by a different operator, as per the procedure described in the original study.
- Subsequent surveys will follow the scheme proposed by Curley et al. (2018), but instead of being organised according to days of the week, they will be divided as follows:
- first survey on the day of enrolment,
- second survey approximately 48 hours later,
- third survey 48 hours after the second survey.
- In the second week of enrolment, starting on the same day as the first survey, the pattern described above is repeated.
- In the following two weeks, the survey will be carried out on the day of the week coinciding with the day of enrolment.
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.
- Keywords
- Neonatal Population, Risk of pressure injury, Braden QDS Scale, Assessment tool, Neonatal Intensive Care Unit, Prevention.
What is being measured
The primary outcome is the main question the study is designed to answer.
.Braden QDS Linguistic-cultural validation (Italian Version)
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
Measured: Study duration 21 months Enrolment duration 18 months Planned monitoring is quarterly and internal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Jul 2020
- Primary completion19 Dec 2027 (estimated)
- Study completion19 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Ulcers in the Neonatal PopulationStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppina Grugnetti, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425418
- Sponsor's protocol ID
- Braden QDS
- Acronym
- BradenQDS
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Validation of a Pressure Injury Risk Assessment Scale (Braden QDS) in the Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07425418
- Acronym / sponsor ID
- BradenQDS / Braden QDS
- Keywords
- Neonatal Population, Risk of pressure injury, Braden QDS Scale, Assessment tool, Neonatal Intensive Care Unit, Prevention.
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 19 Dec 2027 (estimated)
- Study completion
- 19 Apr 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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.
- In the 30 minutes following the meal, the infants are placed in the anti-reflux position, tilting the table about 30°, in order to facilitate gastric emptying and reduce the risk of reflux or regurgitation
- The first measurement of the scale will be carried out, after enrolment and assessment of the hydration status of the skin according to the rating scale in use in the Foundation, following morning hygiene care and the second assessment by the end of the daily shift (maximum within 6 hours) on the day of enrolment, by a different operator, as per the procedure described in the original study.
- Subsequent surveys will follow the scheme proposed by Curley et al. (2018), but instead of being organised according to days of the week, they will be divided as follows:
- first survey on the day of enrolment,
- second survey approximately 48 hours later,
- third survey 48 hours after the second survey.
- In the second week of enrolment, starting on the same day as the first survey, the pattern described above is repeated.
- In the following two weeks, the survey will be carried out on the day of the week coinciding with the day of enrolment.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A convenience sample consisting of infants admitted to the IRCCS Policlinico San Matteo Foundation in Pavia in the Neonatal Intensive Care Unit and Neonatal Pathology Unit will be enrolled. 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. 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. There are cases of delayed postural change linked to the patient's difficulty in maintaining stable vital parameters, which will be reported appropriately in the data collection form. In the 30 minutes following
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
.Braden QDS Linguistic-cultural validation (Italian Version)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcers in the Neonatal Population, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppina Grugnetti, MD (+39 0382501082, g.grugnetti@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
.Braden QDS Linguistic-cultural validation (Italian Version) (time frame: Study duration 21 months Enrolment duration 18 months Planned monitoring is quarterly and internal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.