MOL onderzoek - Microbioom en Onderste Luchtweginfecties
Recruiting
- Conditions
- Healthy children, Microbiome, Lower respitory tract infection, Computer-tailoring
- Registration Number
- NL-OMON23510
- Lead Sponsor
- innaeus Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 975
Inclusion Criteria
All groups:
Children ¡Ý 4 weeks and ¡Ü 5 years and
Exclusion Criteria
Both LRTI and control groups:
1.Severe concomitant disease (severe congenital heart disease, bronchopulmonary dysplasia, prematurity <32 weeks, cystic fibrosis, sickle cell disease, congenital or acquired immunodeficiency disorders, cardiovascular disease, neuromuscular disorders, oncology patients or major congenital anomalies) and/or
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method P microbiome composition and viral presence in the nasopharynx of children hospitalized for a severe and non-severe LRTI and in healthy age- and gender- matched controls.
- Secondary Outcome Measures
Name Time Method Secondary endpoints: <br /><br>1.NP microbiome composition and viruses of LRTI cases after recovery (see above).<br /><br>2.Clinical data from the medical record, routine chest X-ray results and routine laboratory blood parameters of children hospitalized for LRTI. <br /><br>3.Microbiota in saliva (oral cavity), sputum (lower respiratory tract) and faeces (intestines).<br /><br /><br> <br>Exploratory endpoints: <br /><br>Questionnaires for possible influences on the NP-, oral- and intestinal microbiome: pregnancy duration, delivery mode, age, sex, formula versus breast milk in infants, siblings and day care attendance, household smoking, season, previous respiratory infections, allergy, antibiotic consumption, co-morbidities and (other) medication. <br>