Italian Validation of a Pressure Injury Risk Assessment Scale (Braden QDS) in the Neonatal Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- .Braden QDS Linguistic-cultural validation (Italian Version)
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
.Braden QDS Linguistic-cultural validation (Italian Version)
时间窗: 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
次要结局
未报告次要终点
研究者
Giuseppina Grugnetti
RN MSc Director of the Health Professions
Fondazione IRCCS Policlinico San Matteo di Pavia