NCT07425418 Italian Validation of a Pressure Injury Risk Assessment Scale (Braden QDS) in the Neonatal Intensive Care Unit
| NCT ID | NCT07425418 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
| Condition | Pressure Ulcers in the Neonatal Population |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2020-07-01 |
| Primary Completion | 2027-12-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2020-07-01 with a primary completion date of 2027-12-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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?
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07425418 clinical trial?
This trial is open to participants of all sexes, up to 28 Days, studying Pressure Ulcers in the Neonatal Population. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07425418 currently recruiting?
Yes, NCT07425418 is actively recruiting participants. Contact the research team at g.grugnetti@smatteo.pv.it for enrollment information.
Where is the NCT07425418 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT07425418 clinical trial?
NCT07425418 is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. The trial plans to enroll 600 participants.