|- candidate number||21885|
|- NTR Number||NTR5132|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-mrt-2015|
|- Secondary IDs||M012-028 |
|- Public Title||MOL onderzoek - Microbioom en Onderste Luchtweginfecties|
|- Scientific Title||Microbiome and lower respiratory tract infections|
|- hypothesis||Children hospitalized with a lower respiratory tract infection have a different NP microbiome composition compared to healthy children.|
|- Healt Condition(s) or Problem(s) studied||Healthy children, Microbiome, Lower respiratory tract infections, Computer-tailoring|
|- 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
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-sep-2013|
|- planned closingdate||1-jan-2016|
|- Target number of participants||975|
|- Interventions||Observational, case control study. |
|- 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).
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.
|- Timepoints||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.
|- Trial web site||http://wetenschapsbureau.nl/studie/mol|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Wing Ho Man|
|- CONTACT for SCIENTIFIC QUERIES|| Wing Ho Man|
|- Sponsor/Initiator ||Linnaeus Institute|
(Source(s) of Monetary or Material Support)
|Wetenschapsbureau Linneaus instituut Hoofddorp|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||30-mrt-2015 - 30-apr-2015|