New tool could help protect fragile newborns from painful bedsores
NCT ID NCT07425418
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether a risk assessment scale called the Braden QDS can accurately predict pressure injuries (bedsores) in newborns admitted to the Neonatal Intensive Care Unit (NICU). Researchers will enroll 600 newborns under 28 days old and weighing less than 5 kg. The goal is to validate an Italian version of the scale, which includes risk from medical devices, to help nurses and doctors prevent these injuries.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could provide a reliable tool to better predict and prevent pressure injuries in newborns in intensive care.
- What could go wrong
- This is an observational validation study, not a treatment trial. The scale may not prove more accurate than existing methods, and results may not apply outside this single Italian hospital.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2020
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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
- Ages
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Up to 28 days
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fondazione IRCCS Policlinico San Matteo di Pavia
RECRUITINGPavia, Pavia, 27100, Italy