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

2017년 9월 26일 업데이트: Ernestina Azor Martínez, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

911

단계

  • 해당 없음

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

4개월 (어린이)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
DCCs received alcohol-based hand sanitizer and a program educational.
다른 이름들:
  • 교육 개입
실험적: 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.
DCCs received liquid soap and a program educational.
다른 이름들:
  • 교육 개입
간섭 없음: Control group
No hand sanitizer or educational program were used.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
the episodes due to respiratory tract infections
기간: 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
8 moth
The episodes due to gastroenteritis
기간: 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
8 month

2차 결과 측정

결과 측정
측정값 설명
기간
Antibiotic prescribing for respiratory infections
기간: 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
8 month
The direct cost of respiratory and gastrointestinal infections
기간: 8 month
The direct costs of episodes due to respiratory and gastrointestinal infections were measured
8 month

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2013년 11월 1일

기본 완료 (실제)

2014년 6월 30일

연구 완료 (실제)

2015년 12월 30일

연구 등록 날짜

최초 제출

2017년 9월 15일

QC 기준을 충족하는 최초 제출

2017년 9월 26일

처음 게시됨 (실제)

2017년 9월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 9월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 9월 26일

마지막으로 확인됨

2017년 9월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

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

IPD 공유 기간

Currently the database is available, we are waiting for statistical analysis

IPD 공유 지원 정보 유형

  • 수액
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

hand sanitizer에 대한 임상 시험

구독하다