respiratory tract infections and wheezing
Conditions
Interventions
OM-85 versus placebo
Sponsors
Franciscus Gasthuis & Vlietland
Eligibility
Inclusion criteria
Inclusion criteria: Gestational age at delivery between 30+0 and 35+6 weeks Postnatal age at least 6 weeks at randomization & postmenstrual age at least 37 weeks Written informed consent by both parents or formal caregivers
Exclusion criteria
Exclusion criteria: Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (unexpected in this group); hemodynamic significant cardiac disease; immunodeficiency; severe failure to thrive; birth asphyxia with predicted poor neurological out-come; syndrome or serious congenital disorder. Dysmaturity and/or weight
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Doctor diagnosed lower RTI and wheezing episodes in the first year of life. Time to first lower respiratory episodes in the second year of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| • time to first lower RTI or wheezing episode • total number of RTI • total number of wheezing episodes • distribution of viruses • medication use (bronchodilators, corticosteroids, antibiotics) • lung function as measured by expiratory variability index • quality of life • costs- and cost-effectiveness • (serious) adverse events • serum specific IgE (allergen sensitization) at 12 months • infant vaccination titers at 12 months • immune development trajectories; immune maturation • gut and respiratory microbiome composition • biomarkers predictive of high morbidity and/or treatment success | — |
Countries
Netherlands
Outcome results
None listed