Respiratory Tract Infections Clinical Trial
Official title:
Socio-health Impact of a Multifactorial Program of Hand Hygiene on Respiratory and Gastrointestinal Infections in Children Attending in Day-care Centres
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.
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.
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