The Investigation of Methods to Capture Acute Respiratory and Gastrointestinal Infections of Children Aged 1 to 3 Years
Condition: Childhood Infections
MeSH terms: Infections; Communicable Diseases
Study type: Observational

Summary: 
      This study serves as a feasibility study for a birth cohort study to investigate the
      influence of the sequence and load of infections and vaccinations on the development of the
      immune system of children. In this study, the investigators aim to test the methods developed
      to capture acute respiratory and gastrointestinal infections and their consequences of
      children aged 1 to 3 years in Braunschweig, Germany. Furthermore, the investigators want to
      study the influence of the environment on the microbiome of children by comparing children of
      the same child care centre with children from different child care centres. The methods
      developed include a symptom diary which has to be filled out on a daily basis by the parents.
      Furthermore parents are asked to take monthly anterior nasal swabs and stool samples from the
      study child independent from symptoms as well as one sample if symptoms occur. The parents
      are provided with instructions and the first nasal swab will be demonstrated by trained study
      personal. The study is powered to compare nasal swabs taken by the trained staff and the
      parents as primary outcome. Secondary outcome is the performance of reminders sent to the
      study participants. The diary and the specimen will be mailed to the Helmholtz Centre for
      Infection Research where they will be analyzed for the nasal and gut microbiome. The nasal
      swabs taken at the time of an infection will be tested for respiratory viruses. After the
      study period of 3 months parents will be asked about the feasibility and acceptance of the
      symptom diary and taking the nasal swabs and stool specimens by means of questionnaires and
      interviews (face to face and focus groups). This will help our understanding of the
      feasibility and acceptance of the methods developed to capture acute respiratory and
      gastrointestinal infections of children and our understanding of the development and
      composition of the nasal and gut microbiota.
    

Detailed description: 
      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).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children aged one to three years visiting a child care center in Braunschweig, Germany
      
Biospecimen description: 
      Parent-collected anterior-nasal swabs and stool samples
    
Keywords: acute respiratory infections; acute gastrointestinal infections; children; child; symptom diary; nasal swabs; stool samples