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Respiratory Tract InfectionsNCT03294772

Impact of a Multifactorial Program of Hand Hygiene on Infections in Children Attending in Day-care Centres

A study testing hand sanitizer and liquid soap in people with Respiratory Tract Infections and Gastroenteritis, run by Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 4 months to 3 yearsHealthy volunteers can take part
Conditions the study is for
Respiratory Tract Infections, Gastroenteritis
What is being tested?
hand sanitizer and liquid soap
Could I receive a placebo?
No, everyone receives an active treatment
How many people
911 participants
Where
No sites listed yet
Study dates
1 Nov 2013to 30 Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 months to 3 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Inclusion Criteria: 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.

Exclusion Criteria: 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.

About this study

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.

Read the detailed description

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.

Being tested
hand sanitizer, liquid soap
Keywords
Respiratory Tract Infections, gastroenteritis, hand sanitizer, handwashing, day care
Medical subject headings
Respiratory Tract Infections, Gastroenteritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hand sanitizerOther

    Also called educational intervention

    DCCs received alcohol-based hand sanitizer and a program educational.

  • liquid soapOther

    Also called educational intervention

    DCCs received liquid soap and a program educational.

Study groups in NCT03294772
Study groupRoleWhat they receive
Hand sanitizer groupExperimentalDCCs 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.
Receives: Other: hand sanitizer
Liquid soap groupExperimentalDCCs received soap and program educational. The liquid soaps used for handwashing in this study did not contain specific antibacterial component, ph= 5.5.
Receives: Other: liquid soap
Control groupNo interventionNo hand sanitizer or educational program were used.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the episodes due to respiratory tract infections

    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

    Measured: 8 moth

  2. The episodes due to gastroenteritis

    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

    Measured: 8 month

Secondary outcomes (2)

  1. Antibiotic prescribing for respiratory infections

    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

    Measured: 8 month

  2. The direct cost of respiratory and gastrointestinal infections

    The direct costs of episodes due to respiratory and gastrointestinal infections were measured

    Measured: 8 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2017
  2. Study start1 Nov 2013
  3. Primary completion30 Jun 2014
  4. Study completion30 Dec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
911 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03294772
Sponsor's protocol ID
FIBAO
Status last verified
Sep 2017
First submitted
15 Sep 2017
Last updated
27 Sep 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The researchers in this study have participated in: the study protocol, informed consent form, workshops on hand hygiene and transmission of infections and how to prevent it. They will also share statistical Analysis Plan and clinical study report

Publications

  • Azor-Martinez E, Garcia-Mochon L, Lopez-Lacort M, Strizzi JM, Munoz-Vico FJ, Jimenez-Lorente CP, Fernandez-Campos MA, Bueno-Rebollo C, Del Castillo-Aguas G, Balaguer-Martinez JV, Gimenez-Sanchez F. Child Care Center Hand Hygiene Programs' Cost-Effectiveness in Preventing Respiratory Infections. Pediatrics. 2021 Dec 1;148(6):e2021052496. doi: 10.1542/peds.2021-052496.

    PubMed 34814193

  • Azor-Martinez E, Yui-Hifume R, Munoz-Vico FJ, Jimenez-Noguera E, Strizzi JM, Martinez-Martinez I, Garcia-Fernandez L, Seijas-Vazquez ML, Torres-Alegre P, Fernandez-Campos MA, Gimenez-Sanchez F. Effectiveness of a Hand Hygiene Program at Child Care Centers: A Cluster Randomized Trial. Pediatrics. 2018 Nov;142(5):e20181245. doi: 10.1542/peds.2018-1245. Epub 2018 Oct 8.

    PubMed 30297500

Questions about this trial

What is this clinical trial studying?

A study testing hand sanitizer and liquid soap in people with Respiratory Tract Infections and Gastroenteritis, run by Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the episodes due to respiratory tract infections (time frame: 8 moth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03294772, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2017.

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