跳至主要内容
临床试验/NCT03294772
NCT03294772已完成不适用

Socio-health Impact of a Multifactorial Program of Hand Hygiene on Respiratory and Gastrointestinal Infections in Children Attending in Day-care Centres

Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental0 个研究点目标入组 911 人开始时间: 2013年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
911
主要终点
the episodes due to respiratory tract infections

研究概览

简要总结

It is well known that attending Day Care Centres (DCCs) can lead to an increase in the frequency of infections, due to the high incidence at this age and also the ease of transmission among children. This high incidence respiratory tract infections (RTIs) and acute gastroenteritis can also have a significant impact on the cost of health care systems, increasing the number of medical visits, hospitalizations and prescribing medications as symptomatic drugs or unnecessary antibiotics in some cases.The aim of the study was to determine whether a multifactorial hand-hygiene program (handwashing with soap and water vs hand sanitizer vs control group) reduce episodes due to RTIs and gastroenteritis in children attending DCCs. In addition, analyze the cost-effectiveness of these interventions.

详细描述

A randomized, controlled, and open study of 3 cohorts of families with children attending to DCCs, between the ages of 0 and 3, attending 25 DCC (911 children) in Almeria (Spain) was designed. This study was carried out over the course of 8 months (November 2013 to June 2014). A group of DCCs/families will perform hand hygiene with soap and water (SWG), another group with hand sanitizer gel (HSG) and a control group (CG) practiced usual handwashing techniques.

Intervention: The families and DCCs staff randomly assigned to HSG and SWG attended handwashing workshops of 2-hour duration. These took place one month before the beginning of the study. Workshop content included education about the most frequent infections in DCCs, their transmission, prevention, treatment, instructions on how and when hands should be washed, use of hand sanitizers and possible side effects in the HSG. Every 2 weeks, the research assistant and the teachers (staff) performed activities such as stories, songs and posters in the classroom, which are linked to hand hygiene and infection's transmission. In the Children/families in the HSG and SWG were instructed by the researchers, teachers, and research assistant to maintain the usual handwashing procedure after going to the toilet and when their hands were visibly dirty. They also were told to use the hand sanitizer and handwashing with water and liquid soap correctly in the following circumstances: after coming into the classroom; before and after lunch; after playing outside; when they went home; and after coughing; sneezing; or blowing their noses; after diapering.

Parents of the three groups completed the survey on sociodemographic characteristics and questions about hand hygiene referred to when and how their children wash their hands. Progenitors of children whit episodes due to RTIs and gastroenteritis collected the symptoms and handed in the completed form to the teacher. A research assistant collected the absence sheets of the participating classes weekly, called the parents of absent children to enquire about the cause of their absence, visited the classrooms and collaborated with the teachers in activities related to the hygiene of hands.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
4 Months 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between 0 and 3 years old enrolled in the aforementioned DCCs, attended the DCCs for at least 15 hours per week and whose parents/guardians had signed an informed consent document were included.

排除标准

  • Children whit chronic illnesses or medication that could affect their likelihood of contracting an infection. Families who used hydroalcoholic gel prior to the start of the study and/or antiseptic soaps in the control group.

研究组 & 干预措施

Hand sanitizer group

Experimental

DCCs received alcohol-based hand sanitizer and a program educational. Characteristics of the hydroalcoholic gel (Alco aloe gel): chlorhexidine digluconate at 0.2% solution, phenoxyethanol 1%, benzalkonium chloride 0.1%. aloe barbadensis 5%, ethyl alcohol 70%, excipients c.s.p. 100 ml. Alcohol of between 70%, ph = 7-7,5.

干预措施: hand sanitizer (Other)

Liquid soap group

Experimental

DCCs received soap and program educational. The liquid soaps used for handwashing in this study did not contain specific antibacterial component, ph= 5.5.

干预措施: liquid soap (Other)

Control group

No Intervention

No hand sanitizer or educational program were used.

结局指标

主要结局

the episodes due to respiratory tract infections

时间窗: 8 moth

The incidence rate of respiratory tract infections was calculated dividing the number of episodes due to tract respiratory infection by the number of pupils during the period of this study. Incidence rate ratio indicates (IRR): the ratio between incidence rate in 3 study groups

The episodes due to gastroenteritis

时间窗: 8 month

The incidence rate of gastroenteritis was calculated dividing the number of episodes due to gastroenteritis by the number of pupils during the period of this study. Incidence rate ratio indicates (IRR): the ratio between incidence rate in 3 study groups

次要结局

  • Antibiotic prescribing for respiratory infections(8 month)
  • The direct cost of respiratory and gastrointestinal infections(8 month)

研究者

发起方
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ernestina Azor Martínez

Principal Investigador

Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

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