Sponsor study identifier
interventional
911
0 countries
N/A
Study Start
November 1, 2013
Actual (reported)Primary Completion
June 30, 2014
Actual (reported)Study Completion
December 30, 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2013
Actual (reported)June 30, 2014
Actual (reported)December 30, 2015
Actual (reported)September 15, 2017
Actual (reported)September 27, 2017
Actual (reported)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
8 moth
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
8 month
Antibiotic prescribing for respiratory infections
8 month
The direct cost of respiratory and gastrointestinal infections
8 month
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.
DCCs received soap and program educational. The liquid soaps used for handwashing in this study did not contain specific antibacterial component, ph= 5.5.
DCCs received alcohol-based hand sanitizer and a program educational.
DCCs received liquid soap and a program educational.
Contact the study team to confirm eligibility.
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.
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.
911 participants (actual enrollment reported by the registry).
First Submitted
September 15, 2017
First Posted
September 27, 2017
Study Start
November 1, 2013
Actual (reported)Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea
No hand sanitizer or educational program were used.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Primary Completion
June 30, 2014
Actual (reported)Study Completion
December 30, 2015
Actual (reported)Last Updated
September 27, 2017
Record last verified: 2017-09
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
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: