Impact of a Multifactorial Program of Hand Hygiene on Infections in Children Attending in Day-care Centres
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|ClinicalTrials.gov Identifier: NCT03294772|
Recruitment Status : Completed
First Posted : September 27, 2017
Last Update Posted : September 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Tract Infections Gastroenteritis||Other: hand sanitizer Other: liquid soap||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||911 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Socio-health Impact of a Multifactorial Program of Hand Hygiene on Respiratory and Gastrointestinal Infections in Children Attending in Day-care Centres|
|Actual Study Start Date :||November 1, 2013|
|Actual Primary Completion Date :||June 30, 2014|
|Actual Study Completion Date :||December 30, 2015|
Experimental: Hand sanitizer group
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.
Other: hand sanitizer
DCCs received alcohol-based hand sanitizer and a program educational.
Other Name: educational intervention
Experimental: Liquid soap group
DCCs received soap and program educational. The liquid soaps used for handwashing in this study did not contain specific antibacterial component, ph= 5.5.
Other: liquid soap
DCCs received liquid soap and a program educational.
Other Name: educational intervention
No Intervention: Control group
No hand sanitizer or educational program were used.
- the episodes due to respiratory tract infections [ Time Frame: 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 [ Time Frame: 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
- Antibiotic prescribing for respiratory infections [ Time Frame: 8 month ]In this study presence or absence of at least 1 antibiotic prescription for each new episode of the RTIs (upper and low RTIs, otitis, amygdalitis, and bronchitis) was collected during the study period
- The direct cost of respiratory and gastrointestinal infections [ Time Frame: 8 month ]The direct costs of episodes due to respiratory and gastrointestinal infections were measured