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MOL onderzoek - Microbioom en Onderste Luchtweginfecties

Microbiome and lower respiratory tract infections

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23510
Enrollment
975
Registered
2015-03-30
Start date
2013-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy children, Microbiome, Lower respitory tract infection, Computer-tailoring

Interventions

Observational, case control study.

Sponsors

Linnaeus Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All groups: Children ¡Ý 4 weeks and ¡Ü 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 criteria

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 2. Nosocomial infection and/or 3. Language barrier

Design outcomes

Primary

MeasureTime frame
NP 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

MeasureTime frame
Secondary 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.

Contacts

Public ContactWing Ho Man

Spaarne Gasthuis - Wetenschapsbureau

023-8909070

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)