Italian validation of the Braden QD pressure-injury risk scale for newborns in the NICU
Official title: Italian Validation of a Pressure Injury Risk Assessment Scale (Braden QDS) in the Neonatal Intensive Care Unit
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT07425418 · Data updated 2026-11-12
This project will test whether the Italian Braden QD Scale can reliably identify newborns in the NICU who are at risk of developing pressure injuries.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 28 Days |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Status | Recruiting |
| Started | July 1, 2020 |
| Main results expected | December 19, 2027 |
| Study ends | April 19, 2028 |
| Registry record updated | February 20, 2026 |
| Trial ID | NCT07425418 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Newborns admitted to the participating NICU who are less than 28 days old, weigh under 5 kg on admission, and whose parent(s) provide informed consent.
✕Probably not a fit
Infants older than 28 days, weighing more than 5 kg at admission, those cared for outside the participating NICU, or those without parental consent would not be eligible and would not directly benefit from this validation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-centre observational study will validate the Italian translation of the Braden QD Scale in neonates admitted to the NICU at Fondazione IRCCS Policlinico San Matteo di Pavia. Newborns under 28 days old and under 5 kg will receive serial Braden QD assessments by different trained operators, with initial and repeat measurements following a scheduled protocol to measure inter-rater reliability and predictive validity. Routine NICU care (anti‑decubitus mattresses, scheduled repositioning, head support, and documentation of devices) will continue and be recorded so the scale is tested in real-world conditions. Study outcomes will compare Braden QD scores to observed pressure-injury events to estimate sensitivity, specificity, and reliability in this Italian neonatal population.
Why it matters
Potential benefit: If successful, the scale could help clinicians spot newborns at high risk for pressure injuries earlier and focus prevention to reduce wounds and related complications.
How similar studies have gone: Existing pediatric tools like the Braden Q and Glamorgan scales have been studied previously, but validating the Braden QD in Italian neonates—particularly incorporating device-related risk—is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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 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
Where it's running
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Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, Italy Recruiting
Study contacts
- Study coordinator: Giuseppina Grugnetti, MD
- Email: g.grugnetti@smatteo.pv.it
- Phone: +39 0382501082
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.