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MOL onderzoek - Microbioom en Onderste Luchtweginfecties


- candidate number21885
- NTR NumberNTR5132
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-mrt-2015
- Secondary IDsM012-028 
- Public TitleMOL onderzoek - Microbioom en Onderste Luchtweginfecties
- Scientific TitleMicrobiome and lower respiratory tract infections
- ACRONYMMOL
- hypothesisChildren hospitalized with a lower respiratory tract infection have a different NP microbiome composition compared to healthy children.
- Healt Condition(s) or Problem(s) studiedHealthy children, Microbiome, Lower respiratory tract infections, Computer-tailoring
- Inclusion criteriaAll groups:
Children 4 weeks and 5 years and

Non-severe LRTI group:
Hospitalized for a LRTI at a general pediatric ward.

Severe LRTI group:
Hospitalized at the intensive care ward for a severe LRTI

Control group must fulfil all the following criteria:
1. Children matched with LRTI case for age (in years). In addition children < 1 year will be matched for months in two categories: 4 weeks - 6 months or 6 months - 1 year.
2. Matched with hospital admission date of LRTI case + maximal two weeks.
3. Matched for gender.
4. No fever and/or respiratory tract infection (except rhinitis) in the previous four weeks.
5. No use of antibiotics in the previous 3 months.
- Exclusion criteriaBoth 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
2. Nosocomial infection and/or
3. Language barrier
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-sep-2013
- planned closingdate1-jan-2016
- Target number of participants975
- InterventionsObservational, case control study.
- Primary outcomeNP 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 outcomeSecondary endpoints:
1. NP microbiome composition and viruses of LRTI cases after recovery (see above).
2. Clinical data from the medical record, routine chest X-ray results and routine laboratory blood parameters of children hospitalized for LRTI.
3. Microbiota in saliva (oral cavity), sputum (lower respiratory tract) and faeces (intestines).

Exploratory endpoints:
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.
- TimepointsSevere LRTI: following intubation, shortly before extubation, 4-8 weeks after hospitalization.
Non-severe LRTI: on hospital admission, 4-8 weeks after hospitalization.

Controls: once, within 2 weeks after admission date of matched case.
- Trial web sitehttp://wetenschapsbureau.nl/studie/mol
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Wing Ho Man
- CONTACT for SCIENTIFIC QUERIES Wing Ho Man
- Sponsor/Initiator Linnaeus Institute
- Funding
(Source(s) of Monetary or Material Support)
Wetenschapsbureau Linneaus instituut Hoofddorp
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD30-mrt-2015 - 30-apr-2015


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