About this trial
The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (unexpected in this group); hemodynamic significant cardiac disease; immunodefi-ciency; severe failure to thrive; birth asphyxia with predicted poor neurological out-come; syndrome or serious congenital disorder.
Maternal TNF-alpha inhibitors or other immunosuppression during pregnancy and/or breastfeeding
Parents unable to speak and read Dutch/English language
Known allergic hypersensitivity to the active ingredients/substance or to any of the excipients.
Trial design
Parallel
Treatments tested in this trial
Broncho-Vaxom
DrugBroncho-Vaxom is a bacterial extract comprising lyophilised fractions of 21 different inactivated bacterial strains, which are frequently causing RTI.
Placebo
Other interventionPlacebo powder from a capsule will be given, which will be indistinguishable from the active study drug.
Treatment groups
Trial outcomes
Primary outcomes
Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life
Recorded by frequent questionnaires
Secondary outcomes
Time to first lower RTI or wheezing episode
Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life.
Total number of RTI
Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life.
Total number of wheezing episodes
Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life.
Distribution of viruses
Viruses present in the nasofarynx during complaints of lower respiratory tract infection or wheezing. Nasofaryngeal swabs will be taken in case of complaints during the first year of life. In the second year of life this will not be done.
Other outcomes
Gut and respiratory microbiome composition
Measured from faeces and nasofaryngeal swabs taken at age 6-10 weeks, 6 months and 12 months.
Secretory IgA in saliva or nasal lining fluid
Saliva will be collected at age 6-10 weeks, 6 months and 12 months.
Immune maturation: immune cells in nasal epithelium
Collected by nasal scraping at age 6-10 weeks, 6 months and 12 months. Analysed using masscytometry.
Immune maturation: chemokines and cytokines in nasal lining fluid
Collected by nasosorption at age 6-10 weeks, 6 months and 12 months. Analysed using Luminex cyto/chemokine assay.
Sponsors and contacts
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Franciscus Gasthuis
Lead sponsor
Leiden University Medical Center
Collaborator
Maastricht University Medical Center
Collaborator
Erasmus Medical Center
Collaborator