- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Lower Saxony
-
Braunschweig, Lower Saxony, Alemania, 38124
- Helmholtz Centre for Infection Research
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
---|
Reminder group
the reminder group receives every 2 weeks a reminder to fill out the symptom diary (postcard or SMS)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Feasibility and acceptance of taking nasal swabs and stool samples by parents of their child
Periodo de tiempo: after 3 months
|
Feasibility and acceptance of taking nasal swabs and stool samples by parents of their child measured by:
|
after 3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Composition of faecal and nasal microbiome
Periodo de tiempo: at baseline
|
Similarity of the faecal and nasal microbiome among children from one child care centre
|
at baseline
|
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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 6506
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .