The Investigation of Methods to Capture Acute Respiratory and Gastrointestinal Infections of Children Aged 1 to 3 Years

NCT02081833 | Completed DMC

• 1 other identifier: 6506
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Infections

Keywords

acute respiratory infections; acute gastrointestinal infections; children; child; symptom diary; nasal swabs; stool samples

Outcome Measures

Primary Outcomes (1)

• Feasibility and acceptance of taking nasal swabs and stool samples by parents of their child

  Feasibility and acceptance of taking nasal swabs and stool samples by parents of their child measured by: * the comparison of quality of nasal swab taken by trained study personal and swab taken by parents (ß-actin and 16s rRNA) * the number of samples sent back * the feedback by parents (by quantitative and qualitative methods)

  after 3 months

Secondary Outcomes (1)

• Composition of faecal and nasal microbiome

  at baseline

Study Arms (1)

Reminder group

the reminder group receives every 2 weeks a reminder to fill out the symptom diary (postcard or SMS)

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children aged one to three years visiting a child care center in Braunschweig, Germany

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Helmholtz Centre for Infection Research: lead

Study Sites (1)

Helmholtz Centre for Infection Research

Braunschweig, Lower Saxony, 38124, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Parent-collected anterior-nasal swabs and stool samples

Study Officials

• Rafael Mikolajczyk, MD, MSc

  Helmholtz Centre for Infection Research

  PRINCIPAL INVESTIGATOR

• André Karch, MD, MSc

  Helmholtz Centre for Infection Research

  PRINCIPAL INVESTIGATOR

• Beate Zoch, MSc

  Helmholtz Centre for Infection Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 7, 2014
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

DE (1)