- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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).
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Lower Saxony
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Braunschweig, Lower Saxony, Allemagne, 38124
- Helmholtz Centre for Infection Research
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Feasibility and acceptance of taking nasal swabs and stool samples by parents of their child
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Composition of faecal and nasal microbiome
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Rafael Mikolajczyk, MD, MSc, Helmholtz Centre for Infection Research
- Chercheur principal: André Karch, MD, MSc, Helmholtz Centre for Infection Research
- Chercheur principal: Beate Zoch, MSc, Helmholtz Centre for Infection Research
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 6506
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