Childhood InfectionsNCT02081833
The Investigation of Methods to Capture Acute Respiratory and Gastrointestinal Infections of Children Aged 1 to 3 Years
An observational study of Childhood Infections, run by Helmholtz Centre for Infection Research at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Infections
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children aged one to three years visiting a child care center in Braunschweig, Germany
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site
Helmholtz Centre for Infection Research
Braunschweig, Lower Saxony, 38124
About this study
Official title: 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)
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.
Read the 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).
- Conditions
- Childhood Infections
- Keywords
- acute respiratory infections, acute gastrointestinal infections, children, child, symptom diary, nasal swabs, stool samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Reminder group | the reminder group receives every 2 weeks a reminder to fill out the symptom diary (postcard or SMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: after 3 months
Secondary outcomes (1)
Composition of faecal and nasal microbiome
Similarity of the faecal and nasal microbiome among children from one child care centre
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helmholtz Centre for Infection Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafael Mikolajczyk, MD, MSc, Principal investigator, Helmholtz Centre for Infection ResearchAndré Karch, MD, MSc, Principal investigator, Helmholtz Centre for Infection ResearchBeate Zoch, MSc, Principal investigator, Helmholtz Centre for Infection Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081833
- Sponsor's protocol ID
- 6506
- Status last verified
- Jan 2016
- First submitted
- 28 Feb 2014
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02081833
- Acronym / sponsor ID
- 6506
- Conditions
- Childhood Infections
- Keywords
- acute respiratory infections, acute gastrointestinal infections, children, child, symptom diary, nasal swabs, stool samples
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Helmholtz Centre for Infection ResearchUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reminder group | – | –the reminder group receives every 2 weeks a reminder to fill out the symptom diary (postcard or SMS) |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children aged one to three years visiting a child care center in Braunschweig, Germany
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility and acceptance of taking nasal swabs and stool samples by parents of their child
Time frame: after 3 months
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)
1 secondary outcome
Composition of faecal and nasal microbiome
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Mikolajczyk, MD, MSc principal investigator
Helmholtz Centre for Infection Research
André Karch, MD, MSc principal investigator
Helmholtz Centre for Infection Research
Beate Zoch, MSc principal investigator
Helmholtz Centre for Infection Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Infections, run by Helmholtz Centre for Infection Research at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptance of taking nasal swabs and stool samples by parents of their child (time frame: after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.