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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02081833
The Investigation of Methods to Capture Acute Respiratory and Gastrointestinal Infections of Children Aged 1 to 3 Years
The Investigation of Methods to Capture Acute Respiratory and Gastrointestinal Infections of Children Aged 1 to 3 Years. Feasibility Study for the Braunschweig Birth Cohort LöwenKIDS (Infections and the Development of the Immune System)
Visão geral do estudo
Status
Condições
Descrição detalhada
Further study details:
Recruitment takes place in child care centres (CCC) with children under the age of 3 years. In cooperation with the CCC, in the first step, the study is introduced to parents by leaflets and posters. In the second step, the study is personally introduced at the CCC with a brief presentation during an appointment or during the time parents pick up their child. Interested parents are handed out the consent forms and a first questionnaire with contact details to be sent back to the study team. After receipt of the signed informed consent, parents are contacted to schedule the appointment for the demonstration of the first nasal swab and for handing out the materials. From this day on, the 3-months study period starts for the parents. During these three months parents fill out the symptom diary on a daily basis and collect anterior nasal swabs and stool samples on a monthly basis from the study child independent from symptoms, as well as one sample if respiratory or gastrointestinal symptoms occur. 50% of the study participants are randomly chosen for the reminder subgroup; they receive 2-weekly reminders to continue the symptom diary by text messages or postcards.
The diary and the specimen will be mailed to the Helmholtz Centre for Infection Research where they will be stored and analyzed for the nasal and gut microbiome. The nasal swabs taken at the time of an infection will be tested for respiratory viruses, using a polymerase chain reaction (PCR) panel for 5 most common respiratory viruses (adeno-, influenza-, metapneumo-, picorna- and respiratory syncytial virus). All other nasal swabs will be tested for ß-actin and 16s rRNA as indicator for the quality of the nasal swab and the nasal swabs taken by the parents will then be compared with the nasal swabs taken by the trained study staff in a non-inferiority study.
After the study period of 3 months parents will be asked about the feasibility and acceptance of the tasks with questionnaires and interviews (face to face and focus groups).
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Lower Saxony
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Braunschweig, Lower Saxony, Alemanha, 38124
- Helmholtz Centre for Infection Research
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- written informed consent from both parents or legal guardians
- child below the age of three visiting a CCC in Braunschweig, Germany
- parents or guardian with sufficient German language skills to complete study diaries and perform study tasks as required
Exclusion Criteria:
- none
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Reminder group
the reminder group receives every 2 weeks a reminder to fill out the symptom diary (postcard or SMS)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Feasibility and acceptance of taking nasal swabs and stool samples by parents of their child
Prazo: after 3 months
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Feasibility and acceptance of taking nasal swabs and stool samples by parents of their child measured by:
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after 3 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Composition of faecal and nasal microbiome
Prazo: at baseline
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Similarity of the faecal and nasal microbiome among children from one child care centre
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at baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rafael Mikolajczyk, MD, MSc, Helmholtz Centre for Infection Research
- Investigador principal: André Karch, MD, MSc, Helmholtz Centre for Infection Research
- Investigador principal: Beate Zoch, MSc, Helmholtz Centre for Infection Research
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 6506
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