Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:36 AM
Study NCT ID:
NCT07425418
Status:
RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Italian Validation of a Pressure Injury Risk Assessment Scale (Braden QDS) in the Neonatal Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-04-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '.Braden QDS Linguistic-cultural validation (Italian Version)', 'timeFrame': 'Study duration 21 months Enrolment duration 18 months Planned monitoring is quarterly and internal', 'description': "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.\n\nThe 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.\n\nThe third and final phase will consist in the evaluation of the psychometric properties and reliability of the scale, described in the analysis plan"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neonatal Population, Risk of pressure injury, Braden QDS Scale, Assessment tool, Neonatal Intensive Care Unit, Prevention.'], 'conditions': ['Pressure Ulcers in the Neonatal Population']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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\n\nThe 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.\n\nPopulation enrolled:\n\nNewborns 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.\n\n* Newborns admitted to the Neonatal Intensive Care Unit (NICU) who are less than 28 days old at the time of admission,\n* Newborns with a body weight of less than 5 kg, at the time of admission\n\nThe main questions it aims to answer are:\n\n* 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?\n* Can the Braden QD Scale detect and measure the risk of pressure injuries from devices placed on the Neonate?", 'detailedDescription': "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.\n\n* 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\n* 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.\n* 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:\n* first survey on the day of enrolment,\n* second survey approximately 48 hours later,\n* third survey 48 hours after the second survey.\n* In the second week of enrolment, starting on the same day as the first survey, the pattern described above is repeated.\n* In the following two weeks, the survey will be carried out on the day of the week coinciding with the day of enrolment.\n\nAll 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.\n\nWith this scheme, the maximum duration of measurements will be 28 days or until discharge, whichever comes first.\n\nThe appearance of pressure lesions will be grounds for discontinuing the measurements.\n\nA 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.\n\nThe 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.\n\nThe 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.\n\nInfants 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", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe criteria for the inclusion of newborn babies correspond to the eligibility criteria for admission, in accordance with current company protocols, which provide for\n\n* age on admission of less than 28 days,\n* body weight on admission less than 5 kg,\n* 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.\n\nExclusion Criteria:\n\n* age greater than 28 days at the time of admission to the NICU\n* weight greater than 5 kg at the time of admission to the NICU - Lack of Informed Consent from Parents'}, 'identificationModule': {'nctId': 'NCT07425418', 'acronym': 'BradenQDS', 'briefTitle': 'Italian Validation of a Pressure Injury Risk Assessment Scale (Braden QDS) in the Neonatal Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': 'Italian Validation of a Pressure Injury Risk Assessment Scale (Braden QDS) in the Neonatal Intensive Care Unit', 'orgStudyIdInfo': {'id': 'Braden QDS'}}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'state': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppina Grugnetti, MD', 'role': 'CONTACT', 'email': 'g.grugnetti@smatteo.pv.it', 'phone': '+39 0382501082'}], 'facility': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Giuseppina Grugnetti, MD', 'role': 'CONTACT', 'email': 'g.grugnetti@smatteo.pv.it', 'phone': '+39 0382501082'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN MSc Director of the Health Professions', 'investigatorFullName': 'Giuseppina Grugnetti', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}