No registrations found.
ID
Source
Brief title
Health condition
Healthy children, Microbiome, Lower respitory tract infection, Computer-tailoring
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Study objective
Children hospitalized with a lower respiratory tract infection have a different NP microbiome composition compared to healthy children.
Study design
Severe 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.
Intervention
Observational, case control study.
Wing Ho Man
Spaarnepoort 1
Hoofddorp 2134 TM
The Netherlands
023-8909070
Wing Ho Man
Spaarnepoort 1
Hoofddorp 2134 TM
The Netherlands
023-8909070
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4986 |
| NTR-old | NTR5132 |
| Other | : M012-028 |